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OpenTrials
Completed

NCT Number: NCT02739620

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

40 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Vermont College of Medicine

Burlington, Vermont, 05405, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neuromuscular Electrical Stimulation

Device

Neuromuscular electrical stimulation will be performed 5 times/week for one hour each day for 2 months.

Primary outcomes

  1. 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

  2. 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

  3. Intermyofibrillar Mitochondrial Content

    Time frame: Difference between values at baseline at 2 months

    Area fraction of intermyofibrillar mitochondria will be assessed by electron microscopy

Secondary outcomes

  1. Single Muscle Fiber Contractile Velocity

    Time frame: Difference between values at baseline at 2 months

    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.

Sponsors and collaborators

Lead sponsor

University of Vermont

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 15, 2016
Registry last updated
Apr 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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