Exercise and Nutrition Interventions for Platinum Chemotherapy-induced Neuropathy R21 (NCT05452902) | Clinical Trial Compass
TerminatedPhase 2
Exercise and Nutrition Interventions for Platinum Chemotherapy-induced Neuropathy R21
Stopped: Out of time and study resources
United States36 participantsStarted 2023-01-19
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Have a diagnosis of cancer
✓. 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
✓. Be able to read English
✓. Be ≥18 years
Exclusion criteria
✕. 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.
✕. 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.
✕. Have planned surgery or radiation treatment in the 12 weeks after baseline.
What they're measuring
1
CIPN-20 sensory subscale
Timeframe: Time point 2 (approximately 6 weeks), controlling for baseline value
✕. Have current or prior cancer in the spine, brainstem, or brain (to allow standard brain MRI analysis)
✕. Have contraindications for MRI scanning (pacemaker, ferrous metal implants, pregnancy, etc. note that most port-a-caths are safe for MRI scanning)