Exercise and Nutrition Interventions During Chemotherapy K07

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 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.

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

Conditions
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Neuropathy;Peripheral

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…) Be female 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 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 |
| --- | --- | --- |
| Patient-reported sensory symptoms of chemotherapy-induced peripheral neuropathy (CIPN) | 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 |
| --- | --- | --- |
| Sensory loss | Finger tactile sensitivity | 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 | 
| 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 | 
| Patient-reported sensory symptoms of CIPN | 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 3 (approx. 12 weeks) or time point 4 (approx. 25 weeks), controlling for baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chemotherapy