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Trial Title:
Feasibility of Auricular Acupressure for Appetite and Weight in Patients With Stage II-IV Gastric, Esophageal, and Pancreatic Cancer
NCT ID:
NCT05911243
Condition:
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
Stage II Pancreatic Cancer AJCC v8
Stage III Pancreatic Cancer AJCC v8
Stage IV Pancreatic Cancer AJCC v8
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Adenocarcinoma
Pancreatic Neoplasms
Stomach Neoplasms
Esophageal Squamous Cell Carcinoma
Esophageal Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Double (Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Procedure
Intervention name:
Acupressure Therapy
Description:
Undergo auricular acupressure
Arm group label:
Arm I (acupressure therapy)
Other name:
Acupressure
Other name:
Ischemic Compression
Intervention type:
Other
Intervention name:
Best Practice
Description:
Receive usual care
Arm group label:
Arm I (acupressure therapy)
Arm group label:
Arm II (usual care)
Other name:
standard of care
Other name:
standard therapy
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo collection of blood samples
Arm group label:
Arm I (acupressure therapy)
Arm group label:
Arm II (usual care)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Arm I (acupressure therapy)
Arm group label:
Arm II (usual care)
Other name:
Quality of Life Assessment
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.
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fred Hutch/University of Washington Cancer Consortium
Address:
City:
Seattle
Zip:
98109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Blake Langley
Phone:
206-667-3481
Email:
blangley@fredhutch.org
Investigator:
Last name:
Blake Langley
Email:
Principal Investigator
Start date:
July 22, 2024
Completion date:
March 1, 2026
Lead sponsor:
Agency:
University of Washington
Agency class:
Other
Collaborator:
Agency:
National Center for Complementary and Integrative Health (NCCIH)
Agency class:
NIH
Collaborator:
Agency:
National Center for Advancing Translational Sciences (NCATS)
Agency class:
NIH
Source:
University of Washington
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05911243
