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

NCT05911243 | Terminated

• 3 other identifiers: RG1123492NCI-2023-039423KL2TR002317
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Clinical Stage II Esophageal Adenocarcinoma AJCC v8; Clinical Stage II Gastric Cancer AJCC v8; Clinical Stage III Esophageal Adenocarcinoma AJCC v8; Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8; Clinical Stage III Gastric Cancer AJCC v8; Clinical Stage IV Esophageal Adenocarcinoma AJCC v8; Clinical Stage IV Gastric Cancer AJCC v8; Stage II Pancreatic Cancer AJCC v8; Stage III Pancreatic Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8; Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8; Clinical Stage IV Esophageal Squamous Cell Carcinoma AJCC v8

Outcome Measures

Primary Outcomes (5)

• Accrual (feasibility)

  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 15 months

• Retention (feasibility)

  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)

  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)

  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)

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

  Up to 16 weeks

Secondary Outcomes (4)

• Change in appetite

  Baseline to week 4

• Change in appetite

  Baseline to week 8

• Change in body weight (kg)

  Baseline to week 4

• Change in body weight (kg)

  Baseline to week 8

Study Arms (2)

Arm I (acupressure therapy)

EXPERIMENTAL

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

Procedure: Acupressure Therapy; Other: Best Practice; Procedure: Biospecimen Collection; Other: Questionnaire Administration

Arm II (usual care)

ACTIVE COMPARATOR

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

Other: Best Practice; Procedure: Biospecimen Collection; Other: Questionnaire Administration

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of blood samples

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Arm I (acupressure therapy); Arm II (usual care)

Questionnaire Administration OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (acupressure therapy); Arm II (usual care)

Acupressure Therapy PROCEDURE

Undergo auricular acupressure

Also known as: Acupressure, Ischemic Compression

Arm I (acupressure therapy)

Best Practice OTHER

Receive usual care

Also known as: standard of care, standard therapy

Arm I (acupressure therapy); Arm II (usual care)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• National Center for Advancing Translational Sciences (NCATS): collaborator
• University of Washington: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Acupressure; Practice Guidelines as Topic; Standard of Care; Specimen Handling

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Blake Langley

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: June 20, 2023
• Study Start: July 22, 2024
• Primary Completion: July 9, 2025
• Study Completion: July 9, 2025
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 6 months and ending 36 months after publication of results or study protocol, as requested.
• Access Criteria: 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.

Locations

US (1)