This clinical trial tests how well an exercise intervention works in reducing fatigue in patients with breast cancer that has spread to nearby tissue or lymph nodes (locally advanced), that cannot be removed by surgery (unresectable), or that has spread from where it first started (primary site) to other places in the body (metastatic) and who are being treated with trastuzumab-deruxtecan (Enhertu). Cancer-related fatigue is a common symptom experienced by people with breast cancer. It can occur before, during, and after cancer treatment, and may affect daily activities and overall quality of life. Fatigue can be caused by many factors including the underlying cancer itself, cancer treatments, mental health disorders, medication side effects, pain, nausea, vomiting, diarrhea, malnutrition, anemia, and insomnia. Many treatments can be used to treat cancer-related fatigue and exercise has been shown to improve cancer-related fatigue. An exercise intervention that combines aerobic and resistance training may help reduce cancer-related fatigue in patients with locally advanced, unresectable, or metastatic breast cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07203378.
Locations matching your search criteria
United States
Utah
Salt Lake City
Huntsman Cancer Institute/University of UtahStatus: Active
Contact: Roma Bhatia
Phone: 801-585-0255
PRIMARY OBJECTIVE:
I. Test the preliminary efficacy of a 12-week, home-based, unsupervised aerobic and resistance training exercise program on changes in cancer-related fatigue, in patients with metastatic breast cancer recently initiated on Enhertu.
SECONDARY OBJECTIVES:
I. Test the feasibility of the tested 12-week, home-based, unsupervised aerobic and resistance training exercise program.
II. Compare the trajectory of cancer-related fatigue from baseline to week 13 between patients receiving the exercise intervention versus not.
III. Evaluate the preliminary efficacy of the exercise intervention on breast cancer-related quality of life.
IV. Compare the trajectory of breast cancer-related quality of life from baseline to week 13 after initiation of training between patients receiving the exercise intervention versus not.
V. Evaluate the preliminary efficacy of the exercise intervention on exercise engagement.
VI. Compare the trajectory of exercise engagement from baseline to 12 weeks between patients receiving the exercise intervention versus not.
VII. Evaluate the preliminary efficacy of the exercise intervention on physical function.
VIII. Compare the trajectory of physical function from baseline to 12 weeks between patients receiving the exercise intervention versus not.
IX. Evaluate the preliminary efficacy of the exercise intervention on measures of peripheral and central fatigue.
X. Compare the trajectory of measures of peripheral and central fatigue baseline to week 13 after initiation of training between patients receiving the exercise intervention versus not.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive an individualized, home-based, unsupervised aerobic program that increases weekly by 20-minute increments until goal time of 90 weekly minutes is reached and resistance exercise training that increases to two days per week with two sets of 12 repetitions per exercise over 12 weeks.
ARM II: Patients receive usual care for 12 weeks.
After completion of study intervention, patients are followed up for 3 months.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationHuntsman Cancer Institute/University of Utah
Principal InvestigatorRoma Bhatia