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Low Intensity Vibration for Breast Cancer Survivor Muscle Function

N/A

Recruiting

Led By tarah Ballinger, MD

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status of 0-2 at the time of study enrollment

Physically able to stand unassisted for 10 minutes at a time

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 months, and 12 months

Awards & highlights

Study Summary

This trial will test whether low intensity vibration delivered for 10 minutes twice daily can help improve the skeletal muscle function of breast cancer patients who don't exercise regularly.

Who is the study for?

This trial is for early stage breast cancer survivors who are about to start aromatase inhibitor therapy and don't regularly exercise. Participants should be post-menopausal or premenopausal with ovarian suppression, have a good performance status, weigh less than 275 lbs., able to stand unassisted for 10 minutes, and completed primary cancer treatments. Exclusions include severe heart conditions, muscle disorders, metastatic breast cancer, certain bone diseases, chronic renal disease or planned cochlear implant.Check my eligibility

What is being tested?

The study tests the effects of Low Intensity Vibration (LIV) on muscle function in breast cancer survivors using a Macrodyne LivMD plate. Patients will use this device twice daily for ten minutes over twelve months while their muscle power output on a stationary bike is measured against those who wait-listed as controls.See study design

What are the potential side effects?

While not explicitly stated in the provided information, potential side effects may include discomfort from standing on the vibration plate and fatigue from regular use. Any unexpected symptoms experienced during the trial would be monitored closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and am up and about more than 50% of my waking hours.

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I can stand by myself for 10 minutes.

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I am 18 years old or older.

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I have been diagnosed with early or locally advanced breast cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 months, and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 months, and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 months, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean change in energetic capacity measured by peak power generation on a stationary bicycle

Secondary outcome measures

Change in bone mineral density of the lumbar spine by T score

Change in lean body mass

Change in muscle contractile properties including peak power, fatigue resistance, and time to recovery measured by isokinetic knee extension

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Macrodyne LivMD plateExperimental Treatment1 Intervention

Group II: Wait-Listed ControlActive Control1 Intervention

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor

980 Previous Clinical Trials

983,204 Total Patients Enrolled

15 Trials studying Breast Cancer

3,498 Patients Enrolled for Breast Cancer

tarah Ballinger, MDPrincipal InvestigatorIndiana University

Tarah Ballinger, MDPrincipal InvestigatorIndiana University

6 Previous Clinical Trials

241 Total Patients Enrolled

3 Trials studying Breast Cancer

178 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this clinical test still open?

"According to the data on clinicaltrials.gov, this trial is currently seeking applicants. The initial listing was published on September 16th 2019 and it has seen its most recent update as of October 12th 2022."

Answered by AI

How many participants are currently being treated as part of this research endeavor?

"Affirmative. Research hosted on clinicaltrials.gov verifies that this investigation, first posted in September 16th 2019 is currently recruiting participants. A total of 72 subjects are being accepted from 1 site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effect of Low Intensity Vibration (LIV) on Aromatase Inhibitor- Induced Musculoskeletal Dysfunction in Early Stage Breast Cancer Survivors

Tarah J Ballinger, MD 2019. "Effect of Low Intensity Vibration (LIV) on Aromatase Inhibitor- Induced Musculoskeletal Dysfunction in Early Stage Breast Cancer Survivors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03712813.

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