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

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.

Study Overview

• Status: Not yet recruiting
• 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
• Intervention / Treatment: Other: Questionnaire Administration; Other: Best Practice; Procedure: Biospecimen Collection; Procedure: Acupressure Therapy

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: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Blake Langley; Phone Number: 206-667-3481; Email: blangley@fredhutch.org

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutch/University of Washington Cancer Consortium
      • Contact: Blake Langley; Phone Number: 206-667-3481; Email: blangley@fredhutch.org
      • Principal Investigator: Blake Langley

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

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.	Other: Questionnaire Administration; Ancillary studies; Other Names: Quality of Life Assessment; Other: Best Practice; Receive usual care; Other Names: standard of care; standard therapy; Procedure: Biospecimen Collection; Undergo collection of blood samples; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Procedure: Acupressure Therapy; Undergo auricular acupressure; Other Names: Acupressure; Ischemic Compression
Active Comparator: Arm II (usual care); Patients receive usual care on study. Patients also undergo collection of blood samples on study.	Other: Questionnaire Administration; Ancillary studies; Other Names: Quality of Life Assessment; Other: Best Practice; Receive usual care; Other Names: standard of care; standard therapy; Procedure: Biospecimen Collection; Undergo collection of blood samples; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Center for Complementary and Integrative Health (NCCIH); National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: Blake Langley, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: June 12, 2023
• First Submitted That Met QC Criteria: June 12, 2023
• First Posted (Actual): June 20, 2023

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Esophageal Diseases; Pancreatic Diseases; Neoplasms, Squamous Cell; Stomach Neoplasms; Carcinoma; Adenocarcinoma; Pancreatic Neoplasms; Carcinoma, Squamous Cell; Esophageal Neoplasms; Esophageal Squamous Cell Carcinoma
• 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)?: YES
• IPD Plan Description: 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).
• IPD Sharing Time Frame: Beginning 6 months and ending 36 months after publication of results or study protocol, as requested.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No