Status:
COMPLETED
Exercise and Nutrition Interventions During Chemotherapy K07
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Neuropathy;Peripheral
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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 treatment...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
April 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 27 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03858153
Start Date
April 15 2019
End Date
August 27 2025
Last Update
December 22 2025
Active Locations (2)
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1
University of Maryland
Baltimore, Maryland, United States, 21201
2
University of Rochester Medical Center
Rochester, New York, United States, 14642