Feasibility of Auricular Acupressure for Appetite and Weight in Patients With Stage II-IV Gastric, Esophageal, and Pancreatic Cancer
Purpose
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 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
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Supportive Care
- Masking
- Double (Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 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. |
|
|
Active Comparator Arm II (usual care) |
Patients receive usual care on study. Patients also undergo collection of blood samples on study. |
|
Recruiting Locations
Seattle 5809844, Washington 5815135 98109
More Details
- NCT ID
- NCT05911243
- Status
- Recruiting
- Sponsor
- University of Washington
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.