Feasibility of Auricular Acupressure for Appetite and Weight in Patients With Stage II-IV Gastric, Esophageal, and Pancreatic Cancer

Stage IV Pancreatic Cancer AJCC v8 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05911243
• Other study ID #: RG1123492
• Secondary ID: NCI-2023-03942RG
• Status: Recruiting
• Phase: N/A
• Start date: June 8, 2024
• Est. completion date: March 1, 2026

Study information

• Verified date: May 2024
• Source: University of Washington
• Contact: Blake Langley
• Phone: 206-667-3481
• Email: blangley[@]fredhutch.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: March 1, 2026
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 18-65 years of age
• Stage II-IV gastric, esophageal, or pancreatic cancer
• Appetite score on visual analog scale =< 70/100
• Functional Assessment for Anorexia/Cachexia Treatment Subscale (FACT-ACS) score < 37
• 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 or immunomodulators 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

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma
• Carcinoma, Squamous Cell
• 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
• Clinical Stage IV Esophageal Adenocarcinoma AJCC v8
• Clinical Stage IV Esophageal Squamous Cell Carcinoma AJCC v8
• Clinical Stage IV Gastric Cancer AJCC v8
• Esophageal Neoplasms
• Esophageal Squamous Cell Carcinoma
• Pancreatic Neoplasms
• Stage II Pancreatic Cancer AJCC v8
• Stage III Pancreatic Cancer AJCC v8
• Stage IV Pancreatic Cancer AJCC v8
• Stomach Neoplasms

Intervention

Procedure:
• Acupressure Therapy
Undergo auricular acupressure

Other:
• Best Practice
Receive usual care

Procedure:
• Biospecimen Collection
Undergo collection of blood samples

Other:
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
University of Washington	National Center for Advancing Translational Sciences (NCATS), National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Acceptability (feasibility)	Acceptability will be assessed using a random convenience sample of participants and providers through semi-structured interviews.	Up to 16 weeks
Secondary	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
Secondary	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
Secondary	Change in body weight (kg)	Analyses will assess change in each outcome as a change from baseline to week 4.	Baseline to week 4
Secondary	Change in body weight (kg)	Analyses will assess change in each outcome as a change from baseline to week 8.	Baseline to week 8