N/A
N=22
Alternative Exercise Program to Improve Skeletal Muscle Function and Fatigue in Cancer Survivors
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02739620 ↗Enrolled (actual)
22
Serious AEs
4.6%
Results posted
Apr 2023
Primary outcome: Primary: Maximal Calcium-activated Tension Single Muscle Fiber Tension — 185; 172; 172; 168 milliNewtons per millimeter^2
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Neuromuscular electrical stimulation (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Female
- Sponsor
- University of Vermont
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximal Calcium-activated Tension Single Muscle Fiber Tension |
185; 172; 172; 168 | — |
| PRIMARY Cross-sectional Area of Skeletal Muscle Fibers |
2432; 2320; 2694; 2381 | — |
| PRIMARY Intermyofibrillar Mitochondrial Content |
2.72; 2.62; 2.75; 2.56 | — |
| SECONDARY Single Muscle Fiber Contractile Velocity |
2.1; 1.92; 1.92; 1.73 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02739620). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.