Clinical trial NCT05911243: Feasibility of Auricular Acupressure for Appetite and Weight in Patients With Stage II-IV Gastric, Esophageal, and Pancreatic Cancer
Official title: A Randomized Controlled Trial Testing the Effects of an Acupressure Intervention on Appetite and Weight in Patients With Gastric, Esophageal, and Pancreatic Cancer: A Pilot and Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Clinical Stage II Esophageal Adenocarcinoma AJCC v8
Clinical Stage II Esophageal Squamous Cell Carcinoma 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 Esophageal Squamous Cell Carcinoma 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
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2023-06-20
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Accrual (feasibility)
timeFrame: Up to 15 months
measure: Retention (feasibility)
timeFrame: Up to 8 weeks
measure: Intervention adherence (feasibility)
timeFrame: Up to 8 weeks
measure: Intervention fidelity (feasibility)
timeFrame: Up to 8 weeks
measure: Acceptability (feasibility)
timeFrame: Up to 16 weeks
Secondary outcomes:
measure: Change in appetite
timeFrame: Baseline to week 4
measure: Change in appetite
timeFrame: Baseline to week 8
measure: Change in body weight (kg)
timeFrame: Baseline to week 4
measure: Change in body weight (kg)
timeFrame: Baseline to week 8
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Blake Langley
role: PRINCIPAL_INVESTIGATOR
References: