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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Device: Neuromuscular electrical stimulation

• Registration Number: NCT02739620
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-08
• Study First Submitted QC: 2016-04-11
• Study First Posted: 2016-04-15
• Study Start: 2017-10-01
• Primary Completion: 2019-12-02
• Study Completion: 2019-12-02
• Results First Submitted: 2023-02-12
• Status Verified: 2023-03
• Results First Submitted QC: 2023-03-13
• Last Update Submitted: 2023-03-13
• Results First Posted: 2023-04-11
• Last Update Posted: 2023-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 22

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NMES	Neuromuscular electrical stimulation	Neuromuscular electrical stimulation (NMES) group

Primary Outcome Measures

Name	Time	Method
Cross-sectional Area of Skeletal Muscle Fibers	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	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	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 Outcome Measures

Name	Time	Method
Single Muscle Fiber Contractile Velocity	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.

Trial Locations

Locations (1)

University of Vermont College of Medicine; 🇺🇸 Burlington, Vermont, United States