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.
Additional locations may be listed on ClinicalTrials.gov for NCT05911243.
Locations matching your search criteria
United States
Washington
Seattle
Fred Hutch/University of Washington/Seattle Children's Cancer ConsortiumStatus: Active
Contact: Blake Langley
Phone: 206-667-3481
PRIMARY OBJECTIVE:
I. To assess feasibility as assessed by recruitment, adherence, retention, fidelity, and acceptability of an 8-week auricular acupressure intervention plus usual care compared to usual care alone.
SECONDARY OBJECTIVE:
I. To examine the feasibility of collecting primary data on 1) cancer anorexia (low appetite) and 2) body weight following an 8-week auricular acupressure intervention.
EXPLORATORY OBJECTIVE:
I. To examine the feasibility of collecting primary data on 1) circulating inflammatory cytokines (i.e., IL-1beta, IL-4, and TNFalpha) and 2) quality of life (i.e., Functional Assessment of Cancer Therapy-General [FACT-G]) following an 8-week auricular acupressure intervention.
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 I are followed up at 8 weeks after active treatment ends.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationFred Hutch/University of Washington/Seattle Children's Cancer Consortium
Principal InvestigatorBlake Langley
