Breast Cancer Clinical Trial
Official title:
Alternative Exercise Program to Improve Skeletal Muscle Function and Fatigue in Cancer Survivors
Verified date | March 2023 |
Source | University of Vermont |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 22 |
Est. completion date | December 2, 2019 |
Est. primary completion date | December 2, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 40 Years to 70 Years |
Eligibility | Inclusion Criteria: 1. stage I, II or III breast cancer 2. receiving neoadjuvant or adjuvant chemotherapy with or without radiation 3. a body mass index <35 kg/m2. Exclusion Criteria: 1. metastatic disease, a prior history of cancer, excluding non-melanoma skin cancer, or prior receipt of chemotherapy 2. autoimmune, vascular or neuromuscular disease that could alter skeletal muscle 3. prior knee or hip replacement 4. contraindications for use of neuromuscular electrical stimulation, including an implanted cardiac defibrillator or pacemaker, lower extremity blood clot or coagulopathy 5. pregnancy |
Country | Name | City | State |
---|---|---|---|
United States | University of Vermont College of Medicine | Burlington | Vermont |
Lead Sponsor | Collaborator |
---|---|
University of Vermont |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | Intermyofibrillar Mitochondrial Content | Area fraction of intermyofibrillar mitochondria will be assessed by electron microscopy | Difference between values at baseline at 2 months | |
Secondary | 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 |
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