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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02739620
• Other study ID #: M16-333
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: December 2, 2019

Study information

• Verified date: March 2023
• Source: University of Vermont
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 2, 2019
• Est. primary completion date: December 2, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Fatigue

Intervention

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

Locations

Country	Name	City	State
United States	University of Vermont College of Medicine	Burlington	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
University of Vermont

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Intermyofibrillar Mitochondrial Content	Area fraction of intermyofibrillar mitochondria will be assessed by electron microscopy	Difference between values at baseline at 2 months
Secondary	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.	Difference between values at baseline at 2 months