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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
66
Undergo auricular acupressure
Receive usual care
Undergo collection of blood samples
Ancillary studies
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
RECRUITINGAccrual (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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 8 weeks
Acceptability (feasibility)
Acceptability will be assessed using a random convenience sample of participants and providers through semi-structured interviews.
Time frame: Up to 16 weeks
Change in appetite
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 4.
Time frame: Baseline to week 4
Change in appetite
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.
Time frame: Baseline to week 8
Change in body weight (kg)
Analyses will assess change in each outcome as a change from baseline to week 4.
Time frame: Baseline to week 4
Change in body weight (kg)
Analyses will assess change in each outcome as a change from baseline to week 8.
Time frame: Baseline to week 8
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