Exercise Effect on Chemotherapy-Induced Neuropathic Pain

Study Overview
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Brief Summary
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Chemotherapy-induced peripheral neuropathy (CIPN) continues to be a serious healthcare concern. It is painful, persistent, resistant to conventional pain therapies, and results in long-term suffering and decreased quality of life for many cancer survivors. The role of exercise to decrease CIPN-related neuropathic pain (CIPN-NP) will be investigated, with the goal of identifying the mechanisms associated with this therapeutic approach to manage CIPN-NP.

Official Title
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Exercise Effect on Chemotherapy-Induced Neuropathic Pain, Peripheral Nerve Fibers

Conditions
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Cancer, Breast, Cancer, Colorectal, Cancer, Lung, Cancer, Ovarian

Intervention / Treatment
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* Behavioral: aerobic exercise intervention
* Other: control group
* Behavioral: resistive training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis with cancer, stage I-IV History of treatment with oxaliplatin, docetaxel, or paclitaxel, either alone or in combination with other agents Completion of chemotherapy > 6 months < 1 year Ability to walk on a treadmill Medical clearance from oncologist or primary care provider Presence of CIPN per National Cancer Institute Common Toxicity Criteria grade 1-3 (0-no signs/symptoms, 1-minor loss of function, 2-increased symptoms not interfering with activities of daily living (ADLs), 3-severe symptoms interfering with ADL, 4-disabling, and 5 is death) Score on Neuropathic Pain Scale >1 Age 21-70 Exclusion Criteria: Denial of CIPN Other motor/sensory neuropathy caused by other than chemotherapy (i.e.alcohol-related, autoimmune diseases, diabetes) Coronary artery disease History of >1 chemotherapy regimen Musculoskeletal conditions which preclude participation in an exercise training program Pregnancy Regular exerciser, defined as >90 minutes per week of aerobic exercise and any resistive training

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: control<br>This is an attention control group with regular contact by study staff. | Other: control group<br>* weekly contact by study staff with survivorship information offered not related to neuropathy.<br>|
| Experimental: aerobic exercise<br>Aerobic exercise intervention is for 12 weeks 3 times weekly with training on site. | Behavioral: aerobic exercise intervention<br>* Exercise physiologist supervised walking or running on the treadmill 3 times weekly for 12 weeks.<br>|
| Experimental: resistive training<br>Intervention is for 12 weeks 3 times weekly with training on site. | Behavioral: resistive training<br>* Exercise physiologist supervised upper and lower extremity resistive training 3 times weekly for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensory pain | Thermal, mechanical, and vibration sensation by quantitative sensory testing | 13 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nerve fiber density | laboratory examination of skin biopsy samples for measurement of nerve fiber density | 13 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, neuropathy