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Clinical Trials/NCT02739620
NCT02739620
Completed
Not Applicable

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

University of Vermont1 site in 1 country22 target enrollmentOctober 1, 2017
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
University of Vermont
Enrollment
22
Locations
1
Primary Endpoint
Cross-sectional Area of Skeletal Muscle Fibers
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2017
End Date
December 2, 2019
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michael J. Toth, Ph.D.

Associate Professor of Medicine

University of Vermont

Eligibility Criteria

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

Outcomes

Primary Outcomes

Cross-sectional Area of Skeletal Muscle Fibers

Time Frame: Difference between values at baseline at 2 months

Cross-sectional area of skeletal muscle fibers will be evaluated using immunohistochemistry, with specification of all relevant muscle fiber types

Intermyofibrillar Mitochondrial Content

Time Frame: Difference between values at baseline at 2 months

Area fraction of intermyofibrillar mitochondria will be assessed by electron microscopy

Maximal Calcium-activated Tension Single Muscle Fiber Tension

Time Frame: Difference between values at baseline at 2 months

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

Secondary Outcomes

  • Single Muscle Fiber Contractile Velocity(Difference between values at baseline at 2 months)

Study Sites (1)

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