Breast Cancer Clinical Trial
Exercise and Nutrition Interventions During Chemotherapy K07
Summary
Chemotherapy-induced peripheral neuropathy (CIPN) is a highly prevalent and severe side-effect of taxane chemotherapy, often used to treat breast cancer. Unfortunately there are very limited treatments for CIPN. This is a phase II randomized controlled trial to test the preliminary efficacy of exercise vs. nutrition education on CIPN, to systematically investigate the potential roles of inflammation and interoception, and to obtain data with a more accurate effect size to inform a future study.
Eligibility Criteria
Inclusion criteria (subjects must…)
Be female
Have breast cancer
Be scheduled to receive taxane chemotherapy without other neurotoxic chemotherapy (platinums, vinca alkaloids, bortezomib, thalidomide)
Have at least six months life expectancy according to the patient's oncologist or designee
Be able to read English
Be at least 18 years old (no upper limit on age)
Provide written informed consent
Exclusion criteria (subjects must not…)
Be in the active or maintenance stage of exercise behavior (i.e., subjects must be sedentary)
Have physical limitations (e.g., cardiorespiratory, orthopedic, central nervous system) that contraindicate participation in maximal physiological fitness testing and a low/moderate intensity home-based walking and progressive resistance exercise program.
Additional exclusion criteria only for patients performing the MRI scanning (40 of 80 enrolled subjects)
1. Subjects must not have contraindications for MRI scanning (pacemaker, metal implants, pregnancy, chest expander from breast reconstruction, etc.-note that most port-a-caths are safe for MRI scanning)
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There are 2 Locations for this study
Rochester New York, 14642, United States
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