Breast CancerNCT02739620

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

A study testing Neuromuscular electrical stimulation in people with Breast Cancer, run by University of Vermont at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 40 to 70 years, women only
Conditions the study is for: Breast Cancer
What is being tested?: Neuromuscular electrical stimulation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 1 siteUnited States
Study dates: 1 Oct 2017to 2 Dec 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 70 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Vermont College of Medicine
Burlington, Vermont, 05405

Other trials in United States

About this study

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
Being tested: Neuromuscular electrical stimulation
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02739620
Study group	Role	What they receive
NMES	Experimental	Neuromuscular electrical stimulation (NMES) group Receives: Device: Neuromuscular electrical stimulation
Control	No intervention	Control group

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: Difference between values at baseline at 2 months
Intermyofibrillar Mitochondrial Content
Area fraction of intermyofibrillar mitochondria will be assessed by electron microscopy
Measured: Difference between values at baseline at 2 months

Secondary outcomes (1)

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.
Measured: Difference between values at baseline at 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 20172 Dec 2019

First posted15 Apr 2016 (estimated)
Study start1 Oct 2017
Primary completion2 Dec 2019
Study completion2 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Breast CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02739620
Sponsor's protocol ID: M16-333
Status last verified: Mar 2023
First submitted: 8 Apr 2016
Last updated: 11 Apr 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: Research data (deidentified) which documents, supports and validates research findings will be stored on the University of Vermont College of Medicine computer system and will be made available upon final acceptance for publication of the major findings from the proposed studies. This includes raw data generated from all clinical and laboratory-based assessments under a data-sharing agreement.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Alternative Exercise Program to Improve Skeletal Muscle Function and Fatigue in Cancer Survivors
ClinicalTrials.gov ID: NCT02739620
Acronym / sponsor ID: M16-333
Conditions: Breast Cancer
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: University of VermontUniversity, hospital or other
Study start: 1 Oct 2017 (actual)
Primary completion: 2 Dec 2019 (actual)
Study completion: 2 Dec 2019 (actual)
First posted: 15 Apr 2016 (estimated)
Results: Posted 11 Apr 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
NMES	Experimental	Device: Neuromuscular electrical stimulationNeuromuscular electrical stimulation (NMES) group
Control	No intervention	–Control group

Who may qualify

Ages: 40 to 70 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Neuromuscular electrical stimulationNeuromuscular electrical stimulation will be performed 5 times/week for one hour each day for 2 months.	Device	NMES

Primary outcome

Maximal Calcium-activated Tension Single Muscle Fiber Tension
Time frame: 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
Cross-sectional Area of Skeletal Muscle Fibers
Time frame: 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
Time frame: Difference between values at baseline at 2 months
Area fraction of intermyofibrillar mitochondria will be assessed by electron microscopy

1 secondary outcome

Single Muscle Fiber Contractile Velocity
Time frame: Difference between values at baseline at 2 months

Results and safety

Results posted to the registry on 11 Apr 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NMES	12	9
Control	10	8

Primary outcome: Maximal Calcium-activated Tension Single Muscle Fiber Tension

Time frame: Difference between values at baseline at 2 months. Mean (Standard Error). Unit: milliNewtons per millimeter^2

Measure	NMES n = 9	Control n = 8
Baseline testing	185 (10)	172 (10)
Post-intervention testing	172 (9)	168 (10)

Population analysed: The sample sizes reflect the number of volunteers with paired data at both baseline and 2-month testing.

Primary outcome: Cross-sectional Area of Skeletal Muscle Fibers

Time frame: Difference between values at baseline at 2 months. Mean (Standard Error). Unit: micrometers^2

Measure	NMES n = 9	Control n = 8
Baseline testing	2432 (246)	2320 (261)
Post-intervention testing	2694 (246)	2381 (260)

Population analysed: The sample sizes reflect the number of volunteers with paired data at both baseline and 2-month testing.

Primary outcome: Intermyofibrillar Mitochondrial Content

Time frame: Difference between values at baseline at 2 months. Mean (Standard Error). Unit: percentage of image area

Measure	NMES n = 9	Control n = 7
Baseline testing	2.72 (0.24)	2.62 (0.26)
Post-intervention testing	2.75 (0.25)	2.56 (0.26)

Population analysed: The sample sizes reflect the number of volunteers with paired data at both baseline and 2-month testing and the fact that electron microscopy measures could not be completed on one volunteer because of insufficient muscle tissue.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 3 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NMES	0 of 12 (0%)	0 of 12 (0%)	0 of 12
Control	1 of 10 (10%)	1 of 10 (10%)	0 of 10

Limitations and caveats (from the sponsor): Our study was powered to detect effects on skeletal muscle at the cellular level over a short time period during treatment.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Research data (deidentified) which documents, supports and validates research findings will be stored on the University of Vermont College of Medicine computer system and will be made available upon final acceptance for publication of the major findings from the proposed studies. This includes raw data generated from all clinical and laboratory-based assessments under a data-sharing agreement.

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Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced or Metastatic, Estrogen Receptor-Positive, HER2-Negative Breast Cancer
Recurrent Breast Carcinoma, Stage III Breast Cancer AJCC v7
RecruitingPhase 1/2
A Study to Evaluate the Effect of GDC-4198 Alone and in Combination With Giredestrant Versus Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor-Negative (HER2-) Breast Cancer
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael J Toth, PhD principal investigator

University of Vermont

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Neuromuscular electrical stimulation in people with Breast Cancer, run by University of Vermont at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximal Calcium-activated Tension Single Muscle Fiber Tension (time frame: Difference between values at baseline at 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02739620.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2023.