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

Completed · Not applicable

Conditions studied: Breast Cancer

In brief

The purpose of this study is to compare the effect of low intensity vibration (LIV) delivered for 10 minutes twice daily for 12 months on skeletal muscle function, in terms of energetic capacity measured by power generation on a stationary bicycle, among patients with early stage breast cancer planned to initiate aromatase inhibitor therapy who do not currently participate in regular exercise, compared to a wait- listed control.

Key facts

Study ID: NCT03712813
Run by: Indiana University
People needed: 72
Starts: 2019-10-02
Expected to finish: 2025-12-18
Last updated by the study team: 2026-05-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age ≥ 18 years
Diagnosis of DCIS or stage I, II, or III breast cancer 3 Planned to initiate an AI
Post- menopausal defined as ≥ 60 years of age, prior bilateral oophorectomy, or age over 50 and absence of any menstrual periods in the last 12 months, or FSH and estradiol in the menopausal range
Premenopausal patients receiving chemical ovarian suppression are allowed
Prior aromatase inhibitor use (if this is a second primary, for example) is allowed as long as it has been more than 12 months
Prior tamoxifen is allowed if switching to an aromatase inhibitor, as long as it has been 28 days between last tamoxifen dose and the baseline procedures (per the half-life of tamoxifen)
Completion of all primary therapy for breast cancer, including surgery, radiation, and chemotherapy. Patients must be ≥ 21 days from chemotherapy completion and ≥14 days from radiation completion. Ongoing HER2 targeted therapy with trastuzumab or pertuzumab, or TDM1 is allowed. Ongoing therapy with abemaciclib per standard of care is allowed.
Baseline T score > - 2.5 on DXA 6. Body weight less than 275 lbs., as dictated by the weight limit for the LIV platforms 7. ECOG performance status of 0-2 at the time of study enrollment 8. Informed consent and authorization of the release of health information must be obtained according to institutional guidelines 9. Physically able to stand unassisted for 10 minutes at a time 10. Currently not participating in regular exercise (defined as less than 90 minutes of moderate to vigorous exercise per week measured by the RPAQ questionnaire)

You may not qualify if…

Unwilling to co-enroll onto the companion FIT core study (IRB study #1707550885)
Diagnosis of other disorder affecting bone function or turnover, such as Paget's disease, renal osteodystrophy, parathyroid disorders, vitamin D deficiency/osteomalacia, chronic renal disease (Cr > 1.4)
a. Vitamin D will be checked during screening. Patients with Vit D < 20 can be enrolled if supplementation is initiated per the treating physician.
Prior history of non-traumatic, fragility bone fracture
Any muscle or neuromuscular disorder affecting muscle function, such as muscular dystrophy, myositis, or amyotrophic lateral sclerosis
Use of bisphosphonates or denosumab within the prior 12 months
History of retinal detachment
Current or planned pacemaker
Current or planned cochlear implant
Any condition precluding power protocol participation (i.e. riding a stationary bicycle), including: NYHA class III or IV congestive heart failure, uncontrolled angina, myocardial infarction in the prior 12 months, orthopedic surgery in the previous 6 months or plans for orthopedic surgery during the study period, chronic uncontrolled pulmonary conditions such as uncontrolled asthma (symptoms > 2 days/week) or dyspnea requiring oxygen, symptomatic peripheral vascular disease, or any other comorbidity that would interfere with the ability to complete and comply with the protocol in the opinion of the investigator
Metastatic breast cancer
a. History of prior treated malignancies, other than breast cancer, that are now stable, are in remission, and do not require active therapy, are acceptable.
Patients requiring chronic anticoagulation are excluded from participation in the optional muscle biopsy collection.

Where it is running

Indiana University Melvin & Bren Simon Cancer Center — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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