Daglig håndholdt vibrationsterapi
Daglig håndholdt vibrationsterapi til behandling af kemoterapi-induceret perifer neuropati (CIPN): En pilotundersøgelse
The purpose of this pilot study is to determine the safety and feasibility of a daily 3-minute hand-held vibration therapy intervention to reduce the severity of CIPN in the hands. The investigators hypothesize that daily vibration therapy can reduce the severity of patient's CIPN in their hands and improve CIPN-related quality of life. The hope is that results from this study will provide early data on the feasibility, efficacy, and most importantly, safety, of daily 3-minute hand-held vibration therapy needed to justify future clinical trials examining vibration therapy as a potential option for treating CIPN in the future.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Lacy Slayton
- Telefonnummer: (317) 278-6718
- E-mail: lslayton@iu.edu
Undersøgelse Kontakt Backup
- Navn: Cheri West, RN
- Telefonnummer: 317-278-3021
- E-mail: chawest@iu.edu
Studiesteder
-
-
Indiana
-
Avon, Indiana, Forenede Stater, 46123
- Rekruttering
- Indiana University Health West
-
Kontakt:
- Cheri West
- Telefonnummer: 317-278-3021
- E-mail: chawestr@iu.edu
-
Indianapolis, Indiana, Forenede Stater, 46202
- Rekruttering
- Indiana University Melvin & Bren Simon Cancer Center
-
Kontakt:
- Cheri West
- Telefonnummer: 317-278-3021
- E-mail: chawest@iu.edu
-
Indianapolis, Indiana, Forenede Stater, 46202
- Rekruttering
- IU Health Joe & Shelly Schwarz Cancer Center
-
Kontakt:
- Cheri West
- Telefonnummer: 317-278-3021
- E-mail: chawest@iu.edu
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 18 years or older at enrollment
- Able to provide informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
- Have completed chemotherapy ≥ 60 days prior to enrollment
- Were exposed to neurotoxic chemotherapy with one or more of the following agents in the following doses: Paclitaxel (cumulative dose: ≥ 300 mg/m2) Docetaxel (cumulative dose: ≥ 100 mg/m2) Nab-paclitaxel (cumulative dose: ≥ 750 mg/m2) Oxaliplatin (cumulative dose: ≥ 510 mg/m2) Carboplatin (cumulative dose: ≥ 600 mg/m2) Cisplatin (cumulative dose: ≥ 200 mg/m2) Vincristine (cumulative dose: ≥ 4 mg/m2) Bortezomib (cumulative dose: ≥ 16 mg/m)
- Continue to display evidence of sensory CIPN in the hands rated at a Grade ≥ 2 according the National Cancer Institute's Common Toxicity Criteria-Adverse Events (NCI-CTC-AE, Version 5.0) Scale ≥ 60 days post-chemotherapy
- If solid tumor cancer, must have non-metastatic cancer
- Agree to return to clinic for required study related measurements at specified intervals
Exclusion Criteria:
- Have pre-existing neuropathy affecting the hands not related to chemotherapy (e.g., carpal tunnel syndrome, nerve compression, etc.)
- Known diagnosis of diabetes mellitus.
- Known contraindications for vibration therapy to hands, including deep venous thrombosis of the upper extremity or ongoing skin infection.
- Will be receiving concurrent radiation of the upper-extremity
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Vibration Therapy
Patients will hold a hand held vibrating device for 3 minutes on each hand daily for 4 weeks. |
vibration therapy using hand held vibration device |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Rekrutteringsmuligheder - procentdel af patienter, der accepterer at deltage i undersøgelsen efter screening
Tidsramme: rekrutteringsperiode (op til 5 år efter studiestart)
|
rekrutteringsperiode (op til 5 år efter studiestart)
|
|
|
Feasibility of compliance- percentage of vibration therapy sessions completed
Tidsramme: 4 weeks
|
Compliance with the daily vibration therapy sessions will be evaluated using data from a Daily Compliance Form Researchers will calculate the percentage of sessions that were completed calculated for each participant, on each hand. Participant compliance with the intervention will be considered acceptable if participants complete ≥ 80% of the sessions they were assigned. |
4 weeks
|
|
Acceptability of Intervention- percentage of patients who answer agree on acceptability form
Tidsramme: 4 weeks
|
percentage of participants who answer "somewhat agree," "agree," or "strongly agree" on the intervention acceptability form |
4 weeks
|
|
Change in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy Induced Peripheral Neuropathy twenty-item scale (CIPN20) scores
Tidsramme: baseline, week 1, week 2, week 3, week 4
|
CIPN 20 questionnaire scores will be compared to baseline weekly to identify an increase of 30% during the intervention period. The CIPN scores range from 20 to 80 with 80 being consistent with the most severe neuropathy symptoms |
baseline, week 1, week 2, week 3, week 4
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in CIPN Severity via the CIPN20 questionnaire scores
Tidsramme: baseline, weeks 1, 2, 3, and 4, 5, 6, 7, and week 8
|
Summary statistics for the weekly CIPN-20 (n, mean, standard deviation, median, minimum, maximum) |
baseline, weeks 1, 2, 3, and 4, 5, 6, 7, and week 8
|
|
Change in CIPN related Quality of Life via the Chemotherapy Induced Peripheral Neuropathy Quality of Life Scale
Tidsramme: baseline, week 4, week 8
|
Descriptive statistics (frequency and percentage for each category, mean and standard deviation of scores assigned to each category (range: 0-7)) will be used to describe the CIPN-related QOL participants have on each of the three categories related to quality of life |
baseline, week 4, week 8
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Erin Newton, MD, Indiana University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IUSCC-0677
Plan for individuelle deltagerdata (IPD)
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Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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