Chemotherapy-induced Peripheral Neuropathy
Conditions
Keywords
Chemotherapy, Brain, Exercise, Nutrition
Brief summary
Chemotherapy-induced peripheral neuropathy (CIPN) is a highly prevalent and severe side-effect of platinum-based chemotherapy, often used to treat gastrointestinal cancers. 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
University of Maryland, Baltimore
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(subjects must…) 1. Have a diagnosis of cancer 2. Be scheduled to receive platinum chemotherapy (specifically oxaliplatin or cisplatin) without other neurotoxic chemotherapy (taxanes, bortezomib, thalidomide). Patients may be enrolled before their first (preferred), second, or third infusion of neurotoxic chemotherapy 3. Be able to read English 4. Be ≥18 years
Exclusion criteria
(subjects must not…) 1. Be performing regular exercise, which is any planned physical activity (e.g., brisk walking, aerobics, jogging, bicycling, swimming, rowing, weight lifting, resistance training, yoga, pilates, etc.) performed to increase physical fitness. To be considered exercise, physical activity should be performed 3-5 times per week for 20-60 minutes per session and should be done at a level that increases your breathing rate and causes you to break a sweat. 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. 3. Have planned surgery or radiation treatment in the 12 weeks after baseline. Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CIPN-20 sensory subscale | 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 |
|---|---|---|
| CIPN-20 sensory subscale | 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 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). |
| 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). |
| Sensory loss | Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline | Finger and toe tactile sensitivity using monofilaments |
| Cold-induced pain | Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline | Finger cold sensitivity using thermode |
| 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). |
Countries
United States
Outcome results
None listed