Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-03942 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| RG1123492 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium | |
| 3KL2TR002317 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Study closed per SRC Low Accrual Policy.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| National Center for Advancing Translational Sciences (NCATS) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (acupressure therapy) | Experimental | Patients undergo auricular acupressure in addition to their usual care on study. Patients also undergo collection of blood samples on study. |
|
| Arm II (usual care) | Active Comparator | Patients receive usual care on study. Patients also undergo collection of blood samples on study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupressure Therapy | Procedure | Undergo auricular acupressure |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Blake Langley | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
Individual participant data that underlie the results reported in published articles after de-identification may be made available upon request (text, tables, figures, and appendices).
Beginning 6 months and ending 36 months after publication of results or study protocol, as requested.
Researchers and investigators who: 1) provide a methodologically sound proposal to expand on aims in the original, approved proposal; and/or 2) aim to conduct individual, participant-level meta-analyses. Proposals should be directed to blangley@fredhutch.org. To gain access, data requestors will need to sign a data access agreement.
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Dec 28, 2023 | May 13, 2026 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Best Practice | Other | Receive usual care |
|
|
| Biospecimen Collection | Procedure | Undergo collection of blood samples |
|
|
| Questionnaire Administration | Other | Ancillary studies |
|
|
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 |
| ICF_000.pdf |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 2, 2026 |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019050 | Acupressure |
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| D013048 | Specimen Handling |
| ID | Term |
|---|---|
| D064746 | Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
Not provided
Not provided