Auricular Point Akupressur for å håndtere kjemoterapiindusert nevropati
9. juli 2026 oppdatert av: Jennifer Kawi, The University of Texas Health Science Center, Houston
Den foreslåtte randomiserte kontrollstudien vil evaluere aurikulær punktakupressur (APA) på kjemoterapi-indusert nevropati (CIN), nøye vurdere punktspesifisitet og placeboeffekter ved å integrere selvrapporteringstiltak, psykofysiske tiltak (QST), endogene biomarkører (cytokiner) og nevro. -avbildning for å undersøke APAs effekt og underliggende mekanisme(r).
Etterforskerne vil bruke en randomisert kontrollstudie, tre-gruppedesign: (1) APA Group, (2) Sham APA Control og (3) Usual Care Control. En smarttelefonapplikasjon for økologisk øyeblikkelig vurdering (EMA) vil bli brukt til å overvåke APA-overholdelse og fange opp momentan CIN-alvorlighet og bruk av smertestillende midler.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
Kjemoterapi-indusert nevropati (CIN) - smerte, nummenhet eller prikking fordelt i hender og føtter gir vedvarende symptomer som påvirker følelse og balanse hos kreftoverlevere. Opptil 50 % av kreftoverlevere lider fortsatt av CIN 6 år etter behandling. Duloxetine, det eneste anbefalte stoffet av American Society of Clinical Oncology, ble funnet å være overlegen placebo, men forbedret CIN med bare 0,73 poeng (0-10 skala). Ingen effektiv behandling for CIN er etablert bortsett fra trening, med effektstørrelse <0,508. Opioider lindrer CIN-smerter, men langvarig bruk frarådes på det sterkeste på grunn av overforbruk av opioider.
Etterforskerne foreslår å teste aurikulær punktakupressur (APA), en innovativ og skalerbar løsning utviklet fra aurikulær akupunktur. APA er en ikke-invasiv (nåleløs) og aktiv behandling for pasienter med smerte, mens akupunktur er en invasiv (ved hjelp av nåler) og passiv behandling (administrert av en autorisert lege). I APA teipes små frø på spesifikke ørepunkter av en dyktig leverandør, og pasienter trykker på frøene for å stimulere ørepunkter tre ganger daglig, tre minutter per gang, i totalt ni minutter per dag. APA gir smertelindring innen 1-2 minutter etter ørestimulering og opprettholder smertelindring i en måned etter en 4-ukers APA-intervensjon. APA er populært i Taiwan, Kina og Europa. Selv om bruken er sparsom i USA, har et begrenset antall kliniske studier støttet APA i smertebehandling.
Studietype
Intervensjonell
Registrering (Faktiske)
238
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Maryland
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Baltimore, Maryland, Forente stater, 21205
- Johns Hopkins University
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Texas
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Houston, Texas, Forente stater, 77030
- The University of Texas Health Science Center at Houston
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Beskrivelse
Inklusjonskriterier:
- kreftpasienter ≥18 år
- har mottatt en medisin i en av følgende kategorier: platinabasert, vinca alkaloider, bortezomib, eribulin og/eller taxaner
- har fullført sin cellegiftkur tre måneder eller mer før påmelding
- har CIN på grunn av å motta nevrotoksisk kjemoterapi for kreft eller har allerede eksisterende perifer nevropati av en annen etiologi som forverret seg etter kjemoterapi
- har en av gjennomsnittlig smerteintensitet, nummenhet eller prikking i ekstremitetene den forrige uken på grunn av CIN ≥ 4 på en 11-punkts numerisk skala.
Ekskluderingskriterier:
- bruk av et undersøkelsesmiddel for smertekontroll samtidig eller i løpet av de siste 30 dagene
- bruk av et implanterbart medikamentleveringssystem, f.eks. Medtronic SynchroMed®
- tidligere cøliaki plexus blokkering eller annen nevrolytisk smertekontrollbehandling
- andre identifiserte årsaker til smertefulle parestesi som eksisterer før kjemoterapi (f.eks. stråling eller ondartet pleksopati, lumbal eller cervikal radikulopati,)
- allergi mot lateks (båndene for APA inkluderer lateks).
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Auricular Point Akupressur (APA)
APA-armen vil motta personlige ukentlige behandlinger og en selvstyrt smarttelefonapplikasjon med videoer for å forstå og administrere APA.
APA-armen vil motta en personlig frøplassering og en opplæring for deltakeren eller deres omsorgsperson for å plassere frøene på ørepunktene, samt ett zoommøte 1 uke etter første besøk for å trene deltaker og/eller omsorgsperson på frø plassering.
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Personlig plassering av frø og en opplæring for deltakeren eller deres omsorgsperson for å plassere frøene på ørepunktene.
Zoomøkt for frøplassering og APA-coaching, som skal skje etter innledende APA og frøplasseringstrening (innledende trening er enten personlig eller veiledet av videoene fra smarttelefonappen).
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Eksperimentell: Virtual Auricular Point Akupressur (vAPA)
VAPA-armen vil selvadministrere APA ved å plassere frøene i henhold til videoinstruksjonen som finnes i den selvstyrte smarttelefonapplikasjonen for å forstå og administrere APA.
Deltaker og/eller en omsorgsperson vil følge videoinstruksjonen om frøplassering og vil motta én zoomøkt for APA-coaching én uke etter baseline-besøket.
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Zoomøkt for frøplassering og APA-coaching, som skal skje etter innledende APA og frøplasseringstrening (innledende trening er enten personlig eller veiledet av videoene fra smarttelefonappen).
Administrer APA selv ved å plassere frøene i henhold til videoinstruksjonene i den selvstyrte smarttelefonapplikasjonen for å forstå og administrere APA.
Deltaker og/eller en omsorgsperson vil følge videoinstruksjonen om frøplassering.
Andre navn:
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Aktiv komparator: Vanlig pleiekontroll
Usual Care-armen vil fortsette med sin vanlige omsorg.
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Deltakerne vil fortsette med vanlig omsorg fra onkolog.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Pain Severity as Assessed by the Brief Pain Inventory
Tidsramme: Baseline, 1 month after baseline
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Brief Pain Inventory (BPI) assesses worst pain severity.
The scale ranges from 0 (no pain) to 10 (severe pain), a higher score indicates greater pain
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Baseline, 1 month after baseline
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Numbness as Assessed by the Brief Pain Inventory
Tidsramme: Baseline, 1 month after Baseline
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Brief Pain Inventory (BPI) assesses worst numbness.
The scale ranges from 0 (no numbness) to 10 (severe numbness), a higher score indicates greater numbness.
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Baseline, 1 month after Baseline
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Tingling as Assessed by the Brief Pain Inventory
Tidsramme: Baseline, 1 month after baseline
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Brief Pain Inventory (BPI) assesses worst Tingling.
The scale ranges from 0 (no tingling) to 10 (severe tingling), a higher score indicates greater tingling.
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Baseline, 1 month after baseline
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Stiffness as Assessed by the Brief Pain Inventory
Tidsramme: Baseline, 1 month after baseline
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Brief Pain Inventory (BPI) assesses worst stiffness.
The scale ranges from 0 (no stiffness) to 10 (severe stiffness), a higher score indicates greater stiffness.
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Baseline, 1 month after baseline
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Grade of Peripheral Motor Neuropathy as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) Version 4
Tidsramme: Baseline, 1 month after baseline
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Peripheral motor neuropathy is graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
Severity is graded on a scale that ranges from 1 to 5, with higher grade indicating greater severity of neuropathy.
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Baseline, 1 month after baseline
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Grade of Peripheral Sensory Neuropathy as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) Version 4
Tidsramme: Baseline, 1 month after baseline
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Peripheral sensory neuropathy is graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
Severity is graded on a scale that ranges from 1 to 5, with higher grade indicating greater severity of neuropathy.
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Baseline, 1 month after baseline
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Physical Function as Assessed by The Revised BPI-CIN Pain Interference Subscale
Tidsramme: Baseline, 1 month after Baseline
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The BPI-CIN Interference subscale will be used to measure physical function caused by CIN.
The seven items evaluate interference with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life.
Each item is rated on a 0-10 numeric scale (0 = does not interfere; 10 = completely interferes).
The overall score is calculated as the mean of the seven items with a total score ranging from 0 to 10 to determine the level of interference, with higher scores indicating greater interference.
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Baseline, 1 month after Baseline
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Functional Ability as Assessed by Eastern Cooperative Oncology Group (ECOG) Performance Status Scale
Tidsramme: Baseline, 1 month after Baseline
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The ECOG Performance Status Scale describes level of functioning in terms of ability to care for oneself, daily activity, and physical. Score on the ECOG ranges from 0 (fully active and able) to 5 (dead) with higher score indicating lower function: 0 - Fully active, able to carry on all pre-disease performance without restriction
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Baseline, 1 month after Baseline
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Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Physical Function Subscale
Tidsramme: Baseline, 1 month after baseline
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Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - physical function subscale assesses physical function using 4 items, each scored on a 5-point likert scale (1 = Unable to do; 5 = Without any difficulty).
Raw scores ranging from 4 to 20 are converted to standardized T-scores (population mean = 50, Standard deviation = 10) using HealthMeasures tables with a range of approximately 20-80.
The higher T-scores indicate better physical function.
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Baseline, 1 month after baseline
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Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Fatigue Subscale
Tidsramme: Baseline, 1 month after baseline
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Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - fatigue subscale assesses fatigue using 4 items, each scored on a 5-point likert scale (1 = Unable to do; 5 = Without any difficulty).
Raw scores ranging from 4 to 20 are converted to standardized T-scores (population mean = 50, Standard deviation = 10) using HealthMeasures tables with a range of approximately 20-80.
The higher T-scores indicate greater fatigue.
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Baseline, 1 month after baseline
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Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Pain Interference Subscale
Tidsramme: Baseline, 1 month after baseline
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Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - pain interference subscale assesses how pain interferes with daily activities using 4 items, each scored on a 5-point likert scale (1 = Unable to do; 5 = Without any difficulty).
Raw scores ranging from 4 to 20 are converted to standardized T-scores (population mean = 50, Standard deviation = 10) using HealthMeasures tables with a range of approximately 20-80.
The higher T-scores indicate greater pain interference.
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Baseline, 1 month after baseline
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Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Depression Subscale
Tidsramme: Baseline, 1 month after baseline
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Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - depression subscale assesses depression using 4 items, each scored on a 5-point likert scale (1 = Unable to do; 5 = Without any difficulty).
Raw scores ranging from 4 to 20 are converted to standardized T-scores (population mean = 50, Standard deviation = 10) using HealthMeasures tables with a range of approximately 20-80.
The higher T-scores indicate greater depression severity.
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Baseline, 1 month after baseline
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Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Anxiety Subscale
Tidsramme: Baseline, 1 month after baseline
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Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - anxiety subscale assesses anxiety using 4 items, each scored on a 5-point likert scale (1 = Unable to do; 5 = Without any difficulty).
Raw scores ranging from 4 to 20 are converted to standardized T-scores (population mean = 50, Standard deviation = 10) using HealthMeasures tables with a range of approximately 20-80.
The higher T-scores indicate greater anxiety.
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Baseline, 1 month after baseline
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Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Sleep Disturbance Subscale
Tidsramme: Baseline, 1 month after baseline
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Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - sleep disturbance subscale assesses sleep disturbance using 4 items, each scored on a 5-point Likert scale (1 = Unable to do; 5 = Without any difficulty).
Raw scores ranging from 4 to 20 are converted to standardized T-scores (population mean = 50, Standard deviation = 10) using HealthMeasures tables with a range of approximately 20-80.
The higher T-scores indicate greater sleep disturbance.
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Baseline, 1 month after baseline
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Quality of Life as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 -Ability to Participate in Social Activities Subscale
Tidsramme: Baseline, 1 month after baseline
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Patient-Reported Outcomes Measurement Information System (PROMIS) 29 - ability to participate in social activities subscale assesses a participant's perceived ability to engage in usual social roles and activities using 4 items, each scored on a 5-point likert scale (1 = Unable to do; 5 = Without any difficulty).
Raw scores ranging from 4 to 20 are converted to standardized T-scores (population mean = 50, Standard deviation = 10) using HealthMeasures tables with a range of approximately 20-80.
The higher T-scores indicate better and higher functioning social participation.
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Baseline, 1 month after baseline
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Upper Limb Function as Assessed by the Quick Dash Index
Tidsramme: Baseline, 1 month after baseline
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The QuickDASH Index assesses upper limb disability and symptoms.
It evaluates limitations in daily activities (e.g., opening jars, performing housework), as well as pain, tingling, and sleep disturbances.
The total score ranges from 0 (no disability) to 100 (most severe disability), with higher scores indicating greater disability.
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Baseline, 1 month after baseline
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Symptoms Severity as Assessed by the MD Anderson Symptom Severity Inventory
Tidsramme: Baseline, 1 month after Baseline
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The MD Anderson Sympton Severity Inventory assesses severity of 13 common symptoms experienced by patients with cancer.
Each item is rated on a 0-10 numeric scale (0 = not present; 10 = as bad as you can imagine).
The overall symptom severity score is calculated as the mean of the 13 items with a range of 0 to 10, higher scores indicating greater symptom severity.
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Baseline, 1 month after Baseline
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Pain Self Efficacy as Assessed by Pain Self-Efficacy Questionnaire (PSEQ)
Tidsramme: Baseline, 1 month after Baseline
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Pain self-efficacy is assessed using the Pain Self-Efficacy Questionnaire (PSEQ).
This 10-item instrument measures a participant's confidence in performing daily activities, social life and function despite pain.
Each item is rated on a 0-6 scale (0 = Not at all confident; 6 = Completely confident) and total score ranges from 0 to 60, with higher scores indicating greater self-efficacy and greater confidence in coping.
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Baseline, 1 month after Baseline
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Psychological Impact of Pain as Assessed by the Pain Catastrophizing Score
Tidsramme: Baseline, 1 month after Baseline
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The Pain Catastrophizing Scale (PCS) assesses components of catastrophizing: rumination, magnification, and helplessness.
The total score ranges from 0 to 52, with higher scores indicating greater pain catastrophizing.
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Baseline, 1 month after Baseline
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Number of Chronic Overlapping Pain Conditions as Assessed by the Chronic Overlapping Pain Conditions (COPC)
Tidsramme: Baseline, 1 month after Baseline
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Chronic Overlapping Pain Conditions (COPC) are assessed using the Chronic Overlapping Pain Conditions Screener (COPCS).
This instrument identifies the presence of up to 10 common chronic pain conditions.
The COPC total score is calculated as the number of positively identified conditions (answered "Yes"), with higher scores indicating greater pain impact, central sensitization, and severity.
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Baseline, 1 month after Baseline
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Charlson Comorbidity Index
Tidsramme: Baseline
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The Charlson Comorbidity index assesses a participant's comorbidity burden and predicted risk of mortality.
The total score ranges from 0 to 37. A higher score indicates greater comorbidity burden and higher risk of mortality.
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Baseline
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Pain Impact as Assessed by Pain, Enjoyment and General Activity (PEG) Scale
Tidsramme: Baseline, 1 month after baseline
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Pain, Enjoyment and General Activity (PEG) is a three-item questionnaire that assesses pain intensity and its impact patient's daily life.
Each item is rated on a 0-10 scale.
The PEG score is calculated as the mean of three items, resulting in score range of 0 to 10, with a higher scores indicating greater pain severity and functional interference.
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Baseline, 1 month after baseline
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Number of Participants Reporting Opioid Use
Tidsramme: Baseline, Day 28
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Baseline, Day 28
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Opioid Use Per Day as Measured by the Morphine Milligram Equivalents (MME) Per Day
Tidsramme: Baseline, Day 28
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Opioid use will be collected via EMA diary using a questionnaire.
Milligram Morphine Equivalent (MME) will be determined by using an equivalency factor to calculate a dose of morphine equivalent to the ordered opioid.
Daily morphine equivalent dosing is sum of the MME of all opioids a patient is likely to take within 24 hours, and will be calculated to MME for analysis.
Baseline was defined as the first day of opioid use recorded in the EMA diary.
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Baseline, Day 28
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Pressure Pain Threshold (PPT)-Trapezius
Tidsramme: Baseline, 1 month after Baseline
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In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: pressure pain threshold (PPT), Mechanical Temporal Summation (MTS), and Conditioned Pain Modulation (CPM).
To assess PPT, a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 2.9 Newton per centimeter squared (N/cm^2) per second to the participant's trapezius and thumbs.
Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful."
The pressure at which participants indicated that the pressure sensation ''first becomes painful" is reported.
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Baseline, 1 month after Baseline
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Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Pressure Pain Threshold (PPT)-Thumb
Tidsramme: Baseline, 1 month after Baseline
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In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: pressure pain threshold (PPT), Mechanical Temporal Summation (MTS), and Conditioned Pain Modulation (CPM).
To assess PPT, a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 2.9 Newton per centimeter squared (N/cm^2) per second to the participant's trapezius and thumbs.
Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful."
The pressure at which participants indicated that the pressure sensation ''first becomes painful" is reported.
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Baseline, 1 month after Baseline
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Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Mechanical Temporal Summation (MTS)
Tidsramme: Baseline, 1 month after Baseline
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In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: pressure pain threshold (PPT), Mechanical Temporal Summation (MTS), and Conditioned Pain Modulation (CPM).
To assess MTS, a single pinprick stimulus (e.g., via a weighted pinprick stimulator or Neuropen) is applied, followed by a series of 10 rapid, identical stimuli at the same location, usually at a rate of 1/second, to measure the change in pain sensation.
Participants rate their pain after the stimuli using a Numeric Rating Scale (NRS) ranging from 0 to 10, where 0 = no pain and 10 = worst pain imaginable.
A higher score means greater pain sensitivity and increased temporal summation.
MTS is calculated as the increase in pain intensity rating (Δ change score) between the first stimulus and the end of the series.
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Baseline, 1 month after Baseline
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Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Conditioned Pain Modulation (CPM)
Tidsramme: Baseline, 1 month after Baseline
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In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: pressure pain threshold (PPT), Mechanical Temporal Summation (MTS), and Conditioned Pain Modulation (CPM).
CPM was assessed as the change in PPT on the trapezius immediately after the immersion of the contralateral hand up to the wrist in a cold-water bath (Neslab, Portsmouth, NH) at 4 degrees Celsius for 20 seconds.
[ [To assess PPT, a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 2.9 Newton per centimeter squared (N/cm^2) per second to the participant's trapezius.
Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful" to assess pressure pain threshold (PPT).]
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Baseline, 1 month after Baseline
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Functional Connectivity Changes in Salience Network - Basal Ganglia Network (SAL-BGN) as Assessed by fMRI Neuroimaging
Tidsramme: Baseline
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Functional Magnetic Resonance Imaging (fMRI) will be used to assess changes in functional connectivity between the Salience Network and Basal Ganglia Network (SAL-BGN) from baseline to post-intervention (1 month after baseline).
Functional connectivity is calculated based on the correlations in Blood Oxygen Level Dependent (BOLD) signal fluctuations in different brain regions.
Connectivity strength will be quantified using Fisher z-transformed correlation coefficients, with higher values indicating stronger functional connectivity.
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Baseline
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Functional Connectivity Changes in Language Network - Basal Ganglia Network (LAN-BGN) as Assessed by fMRI Neuroimaging
Tidsramme: Baseline, 1 month after Baseline
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Functional Magnetic Resonance Imaging (fMRI) will be used to assess changes in functional connectivity between the Salience Network and Basal Ganglia Network (SAL-BGN) from baseline to post-intervention (1 month after baseline).
Functional connectivity is calculated based on the correlations in Blood Oxygen Level Dependent (BOLD) signal fluctuations in different brain regions.
Connectivity strength will be quantified using Fisher z-transformed correlation coefficients, with higher values indicating stronger functional connectivity.
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Baseline, 1 month after Baseline
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The Grooved Pegboard Test-Dominant Hand
Tidsramme: Baseline, 1 month after baseline
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The Grooved Pegboard Test assesses fine motor skills, speed, and visual-motor coordination.
Participants are asked to place 25 pegs into slots as quickly as possible.
The total time to complete the task is recorded in seconds with dominant hand.
Higher times indicate slower performance and reduced dexterity
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Baseline, 1 month after baseline
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The Grooved Pegboard Test-Non Dominant Hand
Tidsramme: Baseline, 1 month after Baseline
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The Grooved Pegboard Test assesses fine motor skills, speed, and visual-motor coordination.
Participants are asked to place 25 pegs into slots as quickly as possible.
The total time to complete the task is recorded in seconds with non-dominant hand.
Higher times indicate slower performance and reduced dexterity
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Baseline, 1 month after Baseline
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Interleukin-1 Alpha Level (From Plasma)
Tidsramme: Baseline, 1 month after Baseline
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Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
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Baseline, 1 month after Baseline
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Interleukin-1 Beta Level (From Plasma)
Tidsramme: Baseline, 1 month after Baseline
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Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
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Baseline, 1 month after Baseline
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Interleukin-2 Level (From Plasma)
Tidsramme: Baseline, 1 month after Baseline
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Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
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Baseline, 1 month after Baseline
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Interleukin-4 Level (From Plasma)
Tidsramme: Baseline, 1 month after Baseline
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Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
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Baseline, 1 month after Baseline
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Interleukin-6 Level (From Plasma)
Tidsramme: Baseline, 1 month after Baseline
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Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
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Baseline, 1 month after Baseline
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Interleukin-8 Level (From Plasma)
Tidsramme: Baseline, 1 month after Baseline
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Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
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Baseline, 1 month after Baseline
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Interleukin-10 Level (From Plasma)
Tidsramme: Baseline, 1 month after Baseline
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Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
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Baseline, 1 month after Baseline
|
|
Interleukin-12 Level (p40) (From Plasma)
Tidsramme: Baseline, 1 month after Baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after Baseline
|
|
Interleukin-12 Level (p70)-(From Plasma)
Tidsramme: Baseline, 1 month after Baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after Baseline
|
|
Interleukin-13 Level (From Plasma)
Tidsramme: Baseline, 1 month after Baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after Baseline
|
|
Interleukin-17 Level (From Plasma)
Tidsramme: Baseline, 1 month after Baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after Baseline
|
|
Interferon-gamma Level (From Plasma)
Tidsramme: Baseline, 1 month after Baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after Baseline
|
|
Tumor Necrosis Factor-alpha Level (From Plasma)
Tidsramme: Baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline
|
|
Tumor Necrosis Factor-alpha Level (From Plasma)
Tidsramme: 1 month after baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
1 month after baseline
|
|
Transforming Growth Factor-beta Level 1(From Plasma)
Tidsramme: Baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline
|
|
Transforming Growth Factor-beta Level 1 (From Plasma)
Tidsramme: 1 month after baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines (including IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p40 and p70), IL-13, IL-17, IFN-γ, TNF-α, TGF-β) were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
1 month after baseline
|
|
Calcitonin Gene-related Peptide Level(From Plasma)
Tidsramme: Baseline, 1 month after baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after baseline
|
|
Monocyte Chemoattractant Protein-1 Level (From Plasma)
Tidsramme: Baseline, 1 month after baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after baseline
|
|
Eotaxin Level (From Plasma)
Tidsramme: Baseline, 1 month after baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after baseline
|
|
C-reactive Protein Level (From Plasma)
Tidsramme: Baseline, 1 month after baseline
|
Blood samples were collected to measure cytokines and inflammatory biomarkers.
Serum concentrations of cytokines and chemokines were quantified using a multiplex bead-based immunoassay.
Biomarker concentrations were analyzed as indicators of inflammatory response at baseline and 1 month after baseline.
|
Baseline, 1 month after baseline
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Nada Lukkahatai, PHD, MSN, RN, Johns Hopkins University
- Hovedetterforsker: Jennifer Kawi, PhD, MSN, FNP-BC, CNE, FAAN, The University of Texas Health Science Center, Houston
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
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- Yeh CH, Lin WC, Kwai-Ping Suen L, Park NJ, Wood LJ, van Londen GJ, Howard Bovbjerg D. Auricular Point Acupressure to Manage Aromatase Inhibitor-Induced Arthralgia in Postmenopausal Breast Cancer Survivors: A Pilot Study. Oncol Nurs Forum. 2017 Jul 1;44(4):476-487. doi: 10.1188/17.ONF.476-487.
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
8. juli 2021
Primær fullføring (Faktiske)
30. mai 2025
Studiet fullført (Faktiske)
19. mars 2026
Datoer for studieregistrering
Først innsendt
3. juni 2021
Først innsendt som oppfylte QC-kriteriene
3. juni 2021
Først lagt ut (Faktiske)
9. juni 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
4. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HSC-SN-21-1085
- 1R01CA245054-01A1 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .