Alternative Exercise Program to Improve Skeletal Muscle Function and Fatigue in Cancer Survivors

Study Overview
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Brief Summary
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Exercise training has beneficial effects in cancer survivors to minimize some of the side effects of cancer and its treatment and improve long-term prognosis, but there are numerous hurdles for individuals diagnosed with, and being treated for, cancer to participate in exercise programs. The goal of this research study is to begin to evaluate whether exercise training via neuromuscular electrical stimulation (NMES) has beneficial effects on skeletal muscle size and function in cancer survivors.

Official Title
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Alternative Exercise Program to Improve Skeletal Muscle Function and Fatigue in Cancer Survivors

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: Neuromuscular electrical stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: stage I, II or III breast cancer receiving neoadjuvant or adjuvant chemotherapy with or without radiation a body mass index <35 kg/m2. Exclusion Criteria: metastatic disease, a prior history of cancer, excluding non-melanoma skin cancer, or prior receipt of chemotherapy autoimmune, vascular or neuromuscular disease that could alter skeletal muscle prior knee or hip replacement contraindications for use of neuromuscular electrical stimulation, including an implanted cardiac defibrillator or pacemaker, lower extremity blood clot or coagulopathy pregnancy

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 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: NMES<br>Neuromuscular electrical stimulation (NMES) group | Device: Neuromuscular electrical stimulation<br>* Neuromuscular electrical stimulation will be performed 5 times/week for one hour each day for 2 months.<br>|
| No Intervention: Control<br>Control group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal Calcium-activated Tension Single Muscle Fiber Tension | Tension (force per unit muscle fiber cross-sectional area) from segments of chemically-skinned single human muscle fibers will be assessed under maximal calcium-activated condition, with muscle fiber type determined post-measurement by gel electrophoresis | Difference between values at baseline at 2 months | 
| Cross-sectional Area of Skeletal Muscle Fibers | Cross-sectional area of skeletal muscle fibers will be evaluated using immunohistochemistry, with specification of all relevant muscle fiber types | Difference between values at baseline at 2 months | 
| Intermyofibrillar Mitochondrial Content | Area fraction of intermyofibrillar mitochondria will be assessed by electron microscopy | Difference between values at baseline at 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Single Muscle Fiber Contractile Velocity | Single muscle fiber contractile velocity assessed using isotonic load clamps, with muscle fiber type determined post-measurement by gel electrophoresis. The velocity of contraction is expressed relative to the length of the muscle fiber segment evaluated (as measured using a eyepiece micrometer during assessments) per second. | Difference between values at baseline at 2 months |