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Mulighed for akupressur for appetit og vægt hos patienter med trin II-IV gastrisk, spiserørs- og bugspytkirtelkræft

12. oktober 2026 opdateret af: Blake Langley, University of Washington

Et randomiseret kontrolleret forsøg, der tester virkningerne af en akupressur-intervention på appetit og vægt hos patienter med mave-, spiserørs- og bugspytkirtelkræft: En pilot- og gennemførlighedsundersøgelse

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

3

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Washington
      • Seattle, Washington, Forenede Stater, 98109
        • Fred Hutch/University of Washington Cancer Consortium

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andet: Questionnaire Administration

Ancillary studies

Andre navne:
  • Livskvalitetsvurdering
Procedure: Biospecimen Collection

Undergo collection of blood samples

Andre navne:
  • Biologisk prøvesamling
  • Bioprøve indsamlet
  • Prøvesamling
Andet: Best Practice

Receive usual care

Andre navne:
  • plejestandard
  • standard terapi
Procedure: Acupressure Therapy

Undergo auricular acupressure

Andre navne:
  • Akupressur
  • Iskæmisk kompression
Aktiv komparator: Arm II (usual care)

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

Ancillary studies

Andre navne:
  • Livskvalitetsvurdering
Procedure: Biospecimen Collection

Undergo collection of blood samples

Andre navne:
  • Biologisk prøvesamling
  • Bioprøve indsamlet
  • Prøvesamling
Andet: Best Practice

Receive usual care

Andre navne:
  • plejestandard
  • standard terapi

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Washington

Samarbejdspartnere

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

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

22. juli 2024

Primær færdiggørelse (Faktiske)

9. juli 2025

Studieafslutning (Faktiske)

9. juli 2025

Datoer for studieregistrering

Først indsendt

12. juni 2023

Først indsendt, der opfyldte QC-kriterier

12. juni 2023

Først opslået (Faktiske)

20. juni 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. oktober 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (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.

IPD-delingsadgangskriterier

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 Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF

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