Neuropathy;Peripheral
Conditions
Keywords
chemotherapy
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.
Interventions
BEHAVIORALEXCAP Exercise
12 weeks of at-home walking and resistance exercise.
BEHAVIORALNutrition Education
12 weeks of implementing eating tips and tracking food.
Sponsors
National Cancer Institute (NCI)
University of Rochester
Study design
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
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(subjects must…) 1. Be female 2. Have breast cancer 3. Be scheduled to receive taxane chemotherapy without other neurotoxic chemotherapy (platinums, vinca alkaloids, bortezomib, thalidomide) 4. Have at least six months life expectancy according to the patient's oncologist or designee 5. Be able to read English 6. Be at least 18 years old (no upper limit on age) 7. Provide written informed consent
Exclusion criteria
(subjects must not…) 1. Be in the active or maintenance stage of exercise behavior (i.e., subjects must be sedentary) 2. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported sensory symptoms of chemotherapy-induced peripheral neuropathy (CIPN) | 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
| Measure | Time frame | Description |
|---|---|---|
| Sensory loss | Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline | Finger tactile sensitivity |
| Numbness and tingling | Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline | Patient-reported severity of numbness/tingling (0-10). A larger value reflects more severe (worse) symptoms of chemotherapy-induced peripheral neuropathy (CIPN). |
| 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 | CIPN-20 total score (Postma et al 2005). The score includes 20 questions, each rated 1-4, and the score ranges from 20-80 with larger values reflecting more severe (worse) symptoms of chemotherapy-induced peripheral neuropathy (CIPN). |
| Patient-reported sensory symptoms of CIPN | Time point 3 (approx. 12 weeks) or time point 4 (approx. 25 weeks), controlling for baseline | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular function | Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline | Distance walked in six-minute walk test |
| Neuropsychological function | Time point 2 (approx. 6 weeks), controlling for baseline | Brain connectivity via functional magnetic resonance imaging |
| Immunological function | Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline | Inflammatory cytokine concentration via ELISA (IL-6, IL-10, etc.) |
| Musculoskeletal function | Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline | Leg strength via isokinetic dynamometer test |
Countries
United States
Outcome results
None listed