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

University of Washington

Status: Enrolling

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

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05911243

NCI-2023-03942 (Registry Identifier)

3KL2TR002317 (U.S. NIH Grant/Contract)

RG1123492 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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66 participants in 2 patient groups

Arm I (acupressure therapy)

Experimental group

Description:

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

Treatment:

Other: Questionnaire Administration

Other: Best Practice

Procedure: Acupressure Therapy

Procedure: Biospecimen Collection

Arm II (usual care)

Active Comparator group

Description:

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

Treatment:

Other: Questionnaire Administration

Other: Best Practice

Procedure: Biospecimen Collection