Feasibility of Auricular Acupressure for Appetite and Weight in Patients With Stage II-IV Gastric, Esophageal, and Pancreatic Cancer

Not Applicable

Recruiting

• Conditions: Clinical Stage II Gastric Cancer AJCC v8; Clinical Stage III Esophageal Adenocarcinoma AJCC v8; Clinical Stage III Gastric Cancer AJCC v8; Stage III Pancreatic Cancer AJCC v8; Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8; Clinical Stage IV Esophageal Adenocarcinoma AJCC v8; Clinical Stage II Esophageal Adenocarcinoma AJCC v8; Stage II Pancreatic Cancer AJCC v8; Clinical Stage IV Esophageal Squamous Cell Carcinoma AJCC v8; Clinical Stage IV Gastric Cancer AJCC v8
• Interventions: Other: Best Practice; Procedure: Acupressure Therapy; Procedure: Biospecimen Collection; Other: Questionnaire Administration

• Registration Number: NCT05911243
• Lead Sponsor: University of Washington

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-06-12
• Study First Submitted QC: 2023-06-12
• Study First Posted: 2023-06-20
• Study Start: 2024-07-22
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-21
• Primary Completion: 2026-02-01
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• 18-65 years of age
• Stage II-IV gastric, esophageal, or pancreatic cancer
• Appetite score on visual analog scale =< 70/100
• Functional Assessment for Anorexia/Cachexia Treatment Subscale (FACT-ACS) score < 37
• 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 or immunomodulators 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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (acupressure therapy)	Biospecimen Collection	Patients undergo auricular acupressure in addition to their usual care on study. Patients also undergo collection of blood samples on study.
Arm II (usual care)	Best Practice	Patients receive usual care on study. Patients also undergo collection of blood samples on study.
Arm II (usual care)	Biospecimen Collection	Patients receive usual care on study. Patients also undergo collection of blood samples on study.
Arm II (usual care)	Questionnaire Administration	Patients receive usual care on study. Patients also undergo collection of blood samples on study.
Arm I (acupressure therapy)	Best Practice	Patients undergo auricular acupressure in addition to their usual care on study. Patients also undergo collection of blood samples on study.
Arm I (acupressure therapy)	Questionnaire Administration	Patients undergo auricular acupressure in addition to their usual care on study. Patients also undergo collection of blood samples on study.
Arm I (acupressure therapy)	Acupressure Therapy	Patients undergo auricular acupressure in addition to their usual care on study. Patients also undergo collection of blood samples on study.

Primary Outcome Measures

Name	Time	Method
Accrual (feasibility)	Up to 15 months	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.
Acceptability (feasibility)	Up to 16 weeks	Acceptability will be assessed using a random convenience sample of participants and providers through semi-structured interviews.
Intervention adherence (feasibility)	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.
Retention (feasibility)	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.
Intervention fidelity (feasibility)	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.

Secondary Outcome Measures

Name	Time	Method
Change in appetite	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.
Change in body weight (kg)	Baseline to week 8	Analyses will assess change in each outcome as a change from baseline to week 8.

Trial Locations

Locations (1)

Fred Hutch/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States