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

NCT03712813 | Completed DMC FDA Device

• 1 other identifier: IUSCC-0680
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

aromatase inhibitors; low intensity vibration

Outcome Measures

Primary Outcomes (1)

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

  Peak power will be measured using the Power Protocol-B

  Baseline, 6 months, and 12 months

Secondary Outcomes (8)

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

  Baseline, 6 months, and 12 months

• Change in lean body mass

  Baseline, 6 months, and 12 months

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

  Baseline, 6 months, and 12 months

• Change in trabecular and cortical volumetric bone mineral density

  Baseline and 12 months

• Change in serologic bone markers of bone turnover (TGF-beta and NTX) by quantitative measurements using ELISA

  Baseline and 12 months

Study Arms (2)

Macrodyne LivMD plate

EXPERIMENTAL

Device: Macrodyne LivMD plate

Wait-Listed Control

NO INTERVENTION

Interventions

Macrodyne LivMD plate DEVICE

Synchronous (applied to both feet) low intensity vibration for 10 minutes, twice daily for 12 months.

Macrodyne LivMD plate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Melvin & Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Tarah Ballinger, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Medicine

Model Details: Patients will be randomized in a 1:1 ratio to LIV or the standard of care. The total patient enrollment will be 72 patients with 36 patients in each arm. Upon registration, subjects will be randomized and given an automated sequence number.

Study Record Dates

• First Submitted: October 16, 2018
• First Posted: October 19, 2018
• Study Start: October 2, 2019
• Primary Completion: December 18, 2025
• Study Completion: December 18, 2025
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

US (1)