Clinical Stage II Esophageal Adenocarcinoma AJCC v8NCT05911243
Feasibility of Auricular Acupressure for Appetite and Weight in Patients With Stage II-IV Gastric, Esophageal, and Pancreatic Cancer
A study testing Acupressure Therapy, Best Practice and Biospecimen Collection in people with Clinical Stage II Esophageal Adenocarcinoma AJCC v8 and Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8, run by University of Washington at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Clinical Stage II Esophageal Adenocarcinoma AJCC v8, Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8, Clinical Stage II Gastric Cancer AJCC v8
- What is being tested?
- Acupressure Therapy, Best Practice and Biospecimen Collection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2024to 9 Jul 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: 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
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.
Read the 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.
- Conditions
- 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 III Gastric Cancer AJCC v8
- Being tested
- Acupressure Therapy, Best Practice, Biospecimen Collection, Questionnaire Administration
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupressure TherapyProcedure or surgery
Also called Acupressure, Ischemic Compression
Undergo auricular acupressure
Best PracticeOther
Also called standard of care, standard therapy
Receive usual care
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo collection of blood samples
Questionnaire AdministrationOther
Also called Quality of Life Assessment
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Acupressure Therapy; Other: Best Practice; Procedure: Biospecimen Collection; Other: Questionnaire Administration |
| Arm II (usual care) | Active comparator | Patients receive usual care on study. Patients also undergo collection of blood samples on study. Receives: Other: Best Practice; Procedure: Biospecimen Collection; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 8 weeks
Acceptability (feasibility)
Acceptability will be assessed using a random convenience sample of participants and providers through semi-structured interviews.
Measured: Up to 16 weeks
Secondary outcomes (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 4.
Measured: 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.
Measured: Baseline to week 8
Change in body weight (kg)
Analyses will assess change in each outcome as a change from baseline to week 4.
Measured: Baseline to week 4
Change in body weight (kg)
Analyses will assess change in each outcome as a change from baseline to week 8.
Measured: Baseline to week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2023
- Study start22 Jul 2024
- Primary completion9 Jul 2025
- Study completion9 Jul 2025
Why it stopped: Study closed per SRC Low Accrual Policy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Stage II Esophageal Adenocarcinoma AJCC v8Studies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Blake Langley, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05911243
- Sponsor's protocol ID
- RG1123492
- Other IDs
- NCI-2023-03942, RG1123492, 3KL2TR002317
- Status last verified
- May 2026
- First submitted
- 12 Jun 2023
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).