The Effects of Exercise and Nutrition Interventions on Chemotherapy-induced Peripheral Neuropathy and Interoceptive Brain Circuitry
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University of Rochester
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Patient-reported sensory symptoms of chemotherapy-induced peripheral neuropathy (CIPN)
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Masking Description
Assessor and investigator will be masked of Arms to the extent possible (i.e., for some outcomes e.g., biomarkers but not others e.g. symptom tests).
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •(subjects must…)
- •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)
Arms & Interventions
Exercise
Exercise for Cancer Patients (EXCAP©®) involves face-to-face instruction and a prescription for an at-home progressive walking and resistance exercise program.
Intervention: EXCAP Exercise (Behavioral)
Nutrition Education
Nutrition education involves equal time and attention as the exercise arm, but the content covers nutrition for cancer patients and lacks an exercise prescription.
Intervention: Nutrition Education (Behavioral)
Outcomes
Primary Outcomes
Patient-reported sensory symptoms of chemotherapy-induced peripheral neuropathy (CIPN)
Time Frame: Time point 2 (approximately 6 weeks), controlling for baseline value
CIPN-20 sensory subscale (Postma et al 2005). The subscale includes 9 questions, each rated 1-4, and the score ranges from 9-36 with larger values reflecting more severe (worse) symptoms of chemotherapy-induced peripheral neuropathy (CIPN).
Secondary Outcomes
- Sensory loss(Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline)
- Sensory, motor, and autonomic symptoms of CIPN(Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks) or time point 4 (approx. 24 weeks), controlling for baseline)
- Patient-reported sensory symptoms of CIPN(Time point 3 (approx. 12 weeks) or time point 4 (approx. 25 weeks), controlling for baseline)
- Numbness and tingling(Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline)
Investigators
Po-Ju Lin
Assistant Professor
University of Rochester