Exercise and Nutrition Interventions for Platinum Chemotherapy-induced Neuropathy R21

Study Overview
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Brief Summary
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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.

Official Title
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The Effects of Exercise and Nutrition Interventions on Platinum Chemotherapy-induced Peripheral Neuropathy and Interoceptive Brain Circuitry (R21)

Conditions
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Chemotherapy-induced Peripheral Neuropathy

Intervention / Treatment
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* Behavioral: EXCAP Exercise
* Behavioral: Nutrition Education


Participation Criteria
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Eligibility Criteria
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Inclusion criteria (subjects must…) 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 (subjects must not…) 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. Additional exclusion criteria only for patients completing MRI (approximately 40 of 60 enrolled subjects; subjects must not…) 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EXCAP Exercise<br>Exercise for Cancer Patients (EXCAP©®) involves face-to-face instruction and a prescription for an at-home progressive walking and resistance exercise program. | Behavioral: EXCAP Exercise<br>* 12 weeks of at-home walking and resistance exercise.<br>|
| Active Comparator: Nutrition Education<br>Nutrition education involves equal time and attention as the exercise arm, but the content covers nutrition for cancer patients and lacks an exercise prescription. | Behavioral: Nutrition Education<br>* 12 weeks of implementing eating tips and tracking food.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CIPN-20 sensory subscale | 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). | Time point 2 (approximately 6 weeks), controlling for baseline value | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CIPN-20 sensory subscale | 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). | Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks) or time point 4 (approx. 24 weeks), controlling for baseline | 
| Sensory, motor, and autonomic symptoms of CIPN | 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). | Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks) or time point 4 (approx. 24 weeks), controlling for baseline | 
| Sensory loss | Finger and toe tactile sensitivity using monofilaments | Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline | 
| Cold-induced pain | Finger cold sensitivity using thermode | Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline | 
| Numbness and tingling | Patient-reported severity of numbness/tingling (0-10). A larger value reflects more severe (worse) symptoms of chemotherapy-induced peripheral neuropathy (CIPN). | Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chemotherapy, Brain, Exercise, Nutrition