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

NCT02739620 | Completed Results FDA Device

• 1 other identifier: M16-333
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (3)

• 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

  Difference between values at baseline at 2 months

• 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

  Difference between values at baseline at 2 months

• Intermyofibrillar Mitochondrial Content

  Area fraction of intermyofibrillar mitochondria will be assessed by electron microscopy

  Difference between values at baseline at 2 months

Secondary Outcomes (1)

• Single Muscle Fiber Contractile Velocity

  Difference between values at baseline at 2 months

Study Arms (2)

NMES

EXPERIMENTAL

Neuromuscular electrical stimulation (NMES) group

Device: Neuromuscular electrical stimulation

Control

NO INTERVENTION

Control group

Interventions

Neuromuscular electrical stimulation DEVICE

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

NMES

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• stage I, II or III breast cancer
• receiving neoadjuvant or adjuvant chemotherapy with or without radiation
• a body mass index \<35 kg/m2.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Vermont: lead

Study Sites (1)

University of Vermont College of Medicine

Burlington, Vermont, 05405, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Our study was powered to detect effects on skeletal muscle at the cellular level over a short time period during treatment.

Results Point of Contact

• Title: Michael J. Toth
• Organization: University of Vermont

michael.toth@med.uvm.edu

802-656-7989

Study Officials

• Michael J Toth, PhD

  University of Vermont

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: April 8, 2016
• First Posted: April 15, 2016
• Study Start: October 1, 2017
• Primary Completion: December 2, 2019
• Study Completion: December 2, 2019
• Last Updated: April 11, 2023
• Results First Posted: April 11, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)