Back to resultsAlternative Exercise Program to Improve Skeletal Muscle Function and Fatigue in Cancer Survivors
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Neuromuscular electrical stimulation
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer
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
- pregnancy
Sites / Locations
- University of Vermont College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
NMES
Control
Arm Description
Neuromuscular electrical stimulation (NMES) group
Control group
Outcomes
Primary Outcome Measures
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
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
Intermyofibrillar Mitochondrial Content
Area fraction of intermyofibrillar mitochondria will be assessed by electron microscopy
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02739620
Brief Title
Alternative Exercise Program to Improve Skeletal Muscle Function and Fatigue in Cancer Survivors
Official Title
Alternative Exercise Program to Improve Skeletal Muscle Function and Fatigue in Cancer Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
December 2, 2019 (Actual)
Study Completion Date
December 2, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NMES
Arm Type
Experimental
Arm Description
Neuromuscular electrical stimulation (NMES) group
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control group
Intervention Type
Device
Intervention Name(s)
Neuromuscular electrical stimulation
Intervention Description
Neuromuscular electrical stimulation will be performed 5 times/week for one hour each day for 2 months.
Primary Outcome Measure Information:
Title
Maximal Calcium-activated Tension Single Muscle Fiber Tension
Description
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
Time Frame
Difference between values at baseline at 2 months
Title
Cross-sectional Area of Skeletal Muscle Fibers
Description
Cross-sectional area of skeletal muscle fibers will be evaluated using immunohistochemistry, with specification of all relevant muscle fiber types
Time Frame
Difference between values at baseline at 2 months
Title
Intermyofibrillar Mitochondrial Content
Description
Area fraction of intermyofibrillar mitochondria will be assessed by electron microscopy
Time Frame
Difference between values at baseline at 2 months
Secondary Outcome Measure Information:
Title
Single Muscle Fiber Contractile Velocity
Description
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.
Time Frame
Difference between values at baseline at 2 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J Toth, PhD
Organizational Affiliation
University of Vermont
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Vermont College of Medicine
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Alternative Exercise Program to Improve Skeletal Muscle Function and Fatigue in Cancer Survivors
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