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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
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- 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 2 years, during study accrual
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.
The Functional Assessment for Anorexia/Cachexia Treatment Subscale is a 12-item subscale that measures the symptoms and concerns of patients with anorexia/cachexia. The subscale can be used as a standalone instrument. Patients rate each item from 0 to 4 (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very Much). The recall period for each question is "during the past 7 days". As each of the 12 items ranges from 0-4, the range of possible scores is 0-48, with 0 being the worst possible score and 48 the best. To obtain the 0-48 score each negatively-worded item response is recoded so that 0 is a bad response and 4 is good response.
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.
The Functional Assessment for Anorexia/Cachexia Treatment Subscale is a 12-item subscale that measures the symptoms and concerns of patients with anorexia/cachexia. The subscale can be used as a standalone instrument. Patients rate each item from 0 to 4 (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very Much). The recall period for each question is "during the past 7 days". As each of the 12 items ranges from 0-4, the range of possible scores is 0-48, with 0 being the worst possible score and 48 the best. To obtain the 0-48 score each negatively-worded item response is recoded so that 0 is a bad response and 4 is good response.
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.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Principal investigator, Blake Langley, University of Washington
- 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
- Oct 2026
- First submitted
- 12 Jun 2023
- Last updated
- 3 Nov 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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).
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05911243
- Acronym / sponsor ID
- RG1123492
- 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
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study closed per SRC Low Accrual Policy.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), National Center for Advancing Translational Sciences (NCATS)
- Study start
- 22 Jul 2024 (actual)
- Primary completion
- 9 Jul 2025 (actual)
- Study completion
- 9 Jul 2025 (actual)
- First posted
- 20 Jun 2023 (actual)
- Results
- Posted 3 Nov 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (acupressure therapy) | Experimental | Procedure: Acupressure Therapy, Other: Best Practice, Procedure: Biospecimen Collection, Other: Questionnaire AdministrationPatients 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 | Other: Best Practice, Procedure: Biospecimen Collection, Other: Questionnaire AdministrationPatients receive usual care on study. Patients also undergo collection of blood samples on study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupressure TherapyAlso: Acupressure, Ischemic CompressionUndergo auricular acupressure | Procedure or surgery | Arm I (acupressure therapy) |
| Best PracticeAlso: standard of care, standard therapyReceive usual care | Other | Arm I (acupressure therapy), Arm II (usual care) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo collection of blood samples | Procedure or surgery | Arm I (acupressure therapy), Arm II (usual care) |
| Questionnaire AdministrationAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (acupressure therapy), Arm II (usual care) |
Primary outcome
Accrual (Feasibility)
Time frame: Up to 2 years, during study accrual
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.
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.
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.
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.
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.
4 secondary outcomes
Change in Appetite
Time frame: Baseline to week 4
Change in Appetite
Time frame: Baseline to week 8
Change in Body Weight (kg)
Time frame: Baseline to week 4
Change in Body Weight (kg)
Time frame: Baseline to week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Blake Langley principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accrual (Feasibility) (time frame: Up to 2 years, during study accrual). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.