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2024-07-22
2026-02-01
2026-04-30
66
NCT05911243
University of Washington
University of Washington
INTERVENTIONAL
Feasibility of Auricular Acupressure for Appetite and Weight in Patients With Stage II-IV Gastric, Esophageal, and Pancreatic Cancer
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2023-06-12 | N/A | 2025-05-27 |
2023-06-12 | N/A | 2025-05-29 |
2023-06-20 | N/A | 2025-05 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Supportive Care
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Double
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| 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. | PROCEDURE: Acupressure Therapy
OTHER: Best Practice
PROCEDURE: Biospecimen Collection
OTHER: Questionnaire Administration
|
| ACTIVE_COMPARATOR: Arm II (usual care) Patients receive usual care on study. Patients also undergo collection of blood samples on study. | OTHER: Best Practice
PROCEDURE: Biospecimen Collection
OTHER: Questionnaire Administration
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Accrual (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. | 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. | 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. | 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. | Up to 8 weeks |
| Acceptability (feasibility) | Acceptability will be assessed using a random convenience sample of participants and providers through semi-structured interviews. | Up to 16 weeks |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline to week 8 |
| Change in body weight (kg) | Analyses will assess change in each outcome as a change from baseline to week 4. | Baseline to week 4 |
| Change in body weight (kg) | Analyses will assess change in each outcome as a change from baseline to week 8. | Baseline to week 8 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Blake Langley Phone Number: 206-667-3481 Email: blangley@fredhutch.org |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
