- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05911243
Feasibility of Auricular Acupressure for Appetite and Weight in Patients With Stage II-IV Gastric, Esophageal, and Pancreatic Cancer
A Randomized Controlled Trial Testing the Effects of an Acupressure Intervention on Appetite and Weight in Patients With Gastric, Esophageal, and Pancreatic Cancer: A Pilot and Feasibility Study
Study Overview
Status
Conditions
- Stage II Pancreatic Cancer AJCC v8
- Stage III Pancreatic Cancer AJCC v8
- Stage IV Pancreatic Cancer AJCC v8
- Clinical Stage III Gastric Cancer AJCC v8
- Clinical Stage IV Gastric Cancer AJCC v8
- 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 IV Esophageal Adenocarcinoma AJCC v8
- Clinical Stage IV Esophageal Squamous Cell Carcinoma AJCC v8
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98109
- Fred Hutch/University of Washington Cancer Consortium
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- 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.
|
Ancillary studies
Other Names:
Receive usual care
Other Names:
Undergo collection of blood samples
Other Names:
Undergo auricular acupressure
Other Names:
|
|
Active Comparator: Arm II (usual care)
Patients receive usual care on study.
Patients also undergo collection of blood samples on study.
|
Ancillary studies
Other Names:
Receive usual care
Other Names:
Undergo collection of blood samples
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Accrual (feasibility)
Time Frame: Up to 15 months
|
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)
Time Frame: Up to 8 weeks
|
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)
Time Frame: Up to 8 weeks
|
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)
Time Frame: Up to 8 weeks
|
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)
Time Frame: Up to 16 weeks
|
Acceptability will be assessed using a random convenience sample of participants and providers through semi-structured interviews.
|
Up to 16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in appetite
Time Frame: Baseline to week 4
|
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
Time Frame: Baseline to week 8
|
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)
Time Frame: Baseline to week 4
|
Analyses will assess change in each outcome as a change from baseline to week 4.
|
Baseline to week 4
|
|
Change in body weight (kg)
Time Frame: Baseline to week 8
|
Analyses will assess change in each outcome as a change from baseline to week 8.
|
Baseline to week 8
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Blake Langley, Fred Hutch/University of Washington Cancer Consortium
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Neoplasms by Site
- Neoplasms
- Digestive System Neoplasms
- Digestive System Diseases
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Pancreatic Neoplasms
- Health Services Administration
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Therapeutics
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Quality of Health Care
- Complementary Therapies
- Physical Therapy Modalities
- Quality Indicators, Health Care
- Rehabilitation
- Guidelines as Topic
- Quality Assurance, Health Care
- Therapy, Soft Tissue
- Musculoskeletal Manipulations
- Standard of Care
- Specimen Handling
- Practice Guidelines as Topic
- Acupressure
Other Study ID Numbers
- RG1123492 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)
- NCI-2023-03942 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- 3KL2TR002317 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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