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Gjennomførbarhet av øreakupressur for appetitt og vekt hos pasienter med stadium II-IV gastrisk, spiserørs- og bukspyttkjertelkreft

12. oktober 2026 oppdatert av: Blake Langley, University of Washington

En randomisert kontrollert studie som tester effekten av en akupressurintervensjon på appetitt og vekt hos pasienter med mage-, spiserørs- og bukspyttkjertelkreft: En pilot- og gjennomførbarhetsstudie

This clinical trial evaluates the feasibility and acceptability of acupressure to the ear (auricular) to address appetite and weight in patients with stage II-IV gastric, esophageal, or pancreatic cancer. Cancer anorexia, the abnormal loss of appetite, directly leads to cancer-associated weight loss (cachexia) through malnourishment, reduced caloric intake, treatment side-effects, and other modifiable risk factors. Cachexia prolongs length of hospital stay for patients, negatively impacts treatment tolerance and adherence, and reduces overall patient quality of life. Auricular acupressure is a form of micro-acupuncture that exerts its effect by stimulating the central nervous system using adhesive taped pellets applied to specific locations on the external ear. The use of these pellets to deliver auricular acupressure has been shown to improve pain, fatigue, insomnia, nausea and vomiting, depression, and quality of life in both cancer and non-cancer settings. Auricular acupressure is a safe, inexpensive, and non-invasive approach to addressing cancer-related symptoms and treatment side-effects and may be effective at improving appetite and weight loss in stage II-IV gastric, esophageal, and pancreatic cancer patients.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo auricular acupressure in addition to their usual care on study. Patients also undergo collection of blood samples on study.

ARM II: Patients receive usual care on study. Patients also undergo collection of blood samples on study.

After completion of study treatment, patients in Arm II are followed up at 8 weeks after active treatment ends.

Studietype

Intervensjonell

Registrering (Faktiske)

3

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Washington
      • Seattle, Washington, Forente stater, 98109
        • Fred Hutch/University of Washington Cancer Consortium

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 til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • 18-65 years of age
  • Stage II-IV gastric, esophageal, or pancreatic cancer
  • Appetite score on visual analog scale ≤ 70/100
  • At least 60 days of planned systemic treatment, whether already initiated or scheduled to be initiated
  • Access to phone and electronic device for study contacts and questionnaires
  • Willing and able to attend 4 in-person auricular acupressure treatments at the Fred Hutch South Lake Union Clinic
  • Willing and able to perform 4 at-home self-applied treatments of auricular acupressure
  • Participants must not have received acupressure or acupuncture for low appetite within last 30 days
  • Participants must not be actively using corticosteroids, mirtazapine (Remeron), olanzapine (Zyprexa), or Marinol for appetite stimulation at baseline
  • Participants must be able to intake food orally and not require sole or supplemental intravenous nutrition at baseline
  • Participants must not have a history of physiological eating disorders (e.g., anorexia nervosa) in the last 3 years
  • Participants must not have a current known or diagnosed immunodeficiency
  • Participants must have an intact auricular pinna
  • Able to understand and willing to sign written informed consent in English

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Arm I (acupressure therapy)

Patients undergo auricular acupressure in addition to their usual care on study. Patients also undergo collection of blood samples on study.
Annen: Questionnaire Administration

Ancillary studies

Andre navn:
  • Livskvalitetsvurdering
Fremgangsmåte: Biospecimen Collection

Undergo collection of blood samples

Andre navn:
  • Biologisk prøvesamling
  • Bioprøve samlet
  • Prøvesamling
Annen: Best Practice

Receive usual care

Andre navn:
  • velferdstandard
  • standard terapi
Fremgangsmåte: Acupressure Therapy

Undergo auricular acupressure

Andre navn:
  • Akupressur
  • Iskemisk kompresjon
Aktiv komparator: Arm II (usual care)

Patients receive usual care on study. Patients also undergo collection of blood samples on study.
Annen: Questionnaire Administration

Ancillary studies

Andre navn:
  • Livskvalitetsvurdering
Fremgangsmåte: Biospecimen Collection

Undergo collection of blood samples

Andre navn:
  • Biologisk prøvesamling
  • Bioprøve samlet
  • Prøvesamling
Annen: Best Practice

Receive usual care

Andre navn:
  • velferdstandard
  • standard terapi

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Accrual (Feasibility)
Tidsramme: Up to 2 years, during study accrual

Accrual will be measured by the average rate of participants-per-month enrolled into both groups with the goal of 5 patients/month over a 15-month period.
Up to 2 years, during study accrual
Retention (Feasibility)
Tidsramme: Up to 8 weeks

Retention will be measured by the number of participants who remain in the trial and provide data at the closeout visit.
Up to 8 weeks
Intervention Adherence (Feasibility)
Tidsramme: Up to 8 weeks

Adherence will be measured in the intervention group by the number of applied auricular acupressure treatments, with the total possible being 8.
Up to 8 weeks
Intervention Fidelity (Feasibility)
Tidsramme: Up to 8 weeks

Fidelity will be assessed by study team adherence to symptom query and appropriate ear seed point modifications to the standard protocol and accuracy of seed placement according to photographic analysis.
Up to 8 weeks
Acceptability (Feasibility)
Tidsramme: Up to 16 weeks

Acceptability will be assessed using a random convenience sample of participants and providers through semi-structured interviews.
Up to 16 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Appetite
Tidsramme: Baseline to week 4

As measured by the Functional Assessment for Anorexia/Cachexia Treatment Subscale. Analyses will assess change in each outcome as a change from baseline to week 4.

The Functional Assessment for Anorexia/Cachexia Treatment Subscale is a 12-item subscale that measures the symptoms and concerns of patients with anorexia/cachexia. The subscale can be used as a standalone instrument. Patients rate each item from 0 to 4 (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very Much). The recall period for each question is "during the past 7 days". As each of the 12 items ranges from 0-4, the range of possible scores is 0-48, with 0 being the worst possible score and 48 the best. To obtain the 0-48 score each negatively-worded item response is recoded so that 0 is a bad response and 4 is good response.
Baseline to week 4
Change in Appetite
Tidsramme: Baseline to week 8

As measured by the Functional Assessment for Anorexia/Cachexia Treatment Subscale. Analyses will assess change in each outcome as a change from baseline to week 8.

The Functional Assessment for Anorexia/Cachexia Treatment Subscale is a 12-item subscale that measures the symptoms and concerns of patients with anorexia/cachexia. The subscale can be used as a standalone instrument. Patients rate each item from 0 to 4 (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very Much). The recall period for each question is "during the past 7 days". As each of the 12 items ranges from 0-4, the range of possible scores is 0-48, with 0 being the worst possible score and 48 the best. To obtain the 0-48 score each negatively-worded item response is recoded so that 0 is a bad response and 4 is good response.
Baseline to week 8
Change in Body Weight (kg)
Tidsramme: Baseline to week 4

Analyses will assess change in each outcome as a change from baseline to week 4.
Baseline to week 4
Change in Body Weight (kg)
Tidsramme: Baseline to week 8

Analyses will assess change in each outcome as a change from baseline to week 8.
Baseline to week 8

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Washington

Samarbeidspartnere

National Center for Complementary and Integrative Health (NCCIH)
National Center for Advancing Translational Sciences (NCATS)

Etterforskere

  • Hovedetterforsker: Blake Langley, Fred Hutch/University of Washington Cancer Consortium

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)

22. juli 2024

Primær fullføring (Faktiske)

9. juli 2025

Studiet fullført (Faktiske)

9. juli 2025

Datoer for studieregistrering

Først innsendt

12. juni 2023

Først innsendt som oppfylte QC-kriteriene

12. juni 2023

Først lagt ut (Faktiske)

20. juni 2023

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • RG1123492
  • RG1123492 (Annen identifikator: Fred Hutch/University of Washington Cancer Consortium)
  • NCI-2023-03942 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
  • 3KL2TR002317 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Individual participant data that underlie the results reported in published articles after de-identification may be made available upon request (text, tables, figures, and appendices).

IPD-delingstidsramme

Beginning 6 months and ending 36 months after publication of results or study protocol, as requested.

Tilgangskriterier for IPD-deling

Researchers and investigators who: 1) provide a methodologically sound proposal to expand on aims in the original, approved proposal; and/or 2) aim to conduct individual, participant-level meta-analyses. Proposals should be directed to blangley@fredhutch.org. To gain access, data requestors will need to sign a data access agreement.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF

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. .

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