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

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ClinicalTrials.gov Identifier: NCT02739620
Recruitment Status : Recruiting
First Posted : April 15, 2016
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
Michael J. Toth, Ph.D., University of Vermont

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Device: Neuromuscular electrical stimulation Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Alternative Exercise Program to Improve Skeletal Muscle Function and Fatigue in Cancer Survivors
Study Start Date : April 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NMES
Neuromuscular electrical stimulation (NMES) group
Device: Neuromuscular electrical stimulation
Neuromuscular electrical stimulation will be performed 5 times/week for one hour each day for 2 months.

No Intervention: Control
Control group



Primary Outcome Measures :
  1. Maximal calcium-activated tension single muscle fiber tension [ Time Frame: Change from baseline tension 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: Change from baseline cross-sectional area 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: Change from baseline mitochondrial content at 2 months ]
    Area fraction of intermyofibrillar mitochondria will be assessed by electron microscopy

  4. Mitochondrial function [ Time Frame: Change from baseline mitochondrial function at 2 months ]
    Oxygen consumption rate of isolated muscle mitochondria under adenosine diphosphate stimulation


Secondary Outcome Measures :
  1. Single muscle fiber contractile velocity [ Time Frame: Change from baseline contractile velocity at 2 months ]
    Single muscle fiber contractile velocity assessed using isotonic load clamps, with muscle fiber type determined post-measurement by gel electrophoresis



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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02739620


Contacts
Contact: Britta MacAlpine 802-735-6509 Britta.MacAlpine@uvmhealth.org

Locations
United States, Vermont
University of Vermont College of Medicine Recruiting
Burlington, Vermont, United States, 05405
Contact: Britta MacAlpine    802-735-6509    britta.macalpine@uvmhealth.org   
Sponsors and Collaborators
University of Vermont
Investigators
Principal Investigator: Michael J Toth, PhD University of Vermont

Responsible Party: Michael J. Toth, Ph.D., Associate Professor of Medicine, University of Vermont
ClinicalTrials.gov Identifier: NCT02739620     History of Changes
Other Study ID Numbers: M16-333
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Research data (deidentified) which documents, supports and validates research findings will be stored on the University of Vermont College of Medicine computer system and will be made available upon final acceptance for publication of the major findings from the proposed studies. This includes raw data generated from all clinical and laboratory-based assessments under a data-sharing agreement.

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms