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

NCT ID: NCT02739620

Last Updated: 2023-04-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2019-12-02

Brief Summary

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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

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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NMES

Neuromuscular electrical stimulation (NMES) group

Group Type EXPERIMENTAL

Neuromuscular electrical stimulation

Intervention Type DEVICE

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

Control

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Neuromuscular electrical stimulation

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Vermont

OTHER

Sponsor Role lead

Responsible Party

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Michael J. Toth, Ph.D.

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael J Toth, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Vermont

Locations

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University of Vermont College of Medicine

Burlington, Vermont, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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M16-333

Identifier Type: -

Identifier Source: org_study_id

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