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Aromatase Inhibitors

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

Macrodyne LivMD plate

Jackson Richey

Tarah Ballinger, MD

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.

This is a randomized phase II, two arm, single-center study designed to compare the effect of LIV versus wait-list control on the clinical parameter of energetic capacity, or power generation, in patients with early stage breast cancer receiving aromatase inhibitor therapy over a 12-month period. The primary endpoint is the 12-month change in energetic capacity since baseline.

Primary Objective To compare the effect of 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

Secondary Objectives

1. To compare the effect of LIV versus wait-listed control upon muscle contractile properties including peak power, fatigue resistance, and recovery, measured by isokinetic knee extension
2. To compare the effect of LIV versus wait- listed control upon body composition (lean mass, total adiposity) measured by DXA scan
3. To compare the effect of LIV versus wait- listed control upon bone mineral density (T score) measured by DXA scan
4. To compare the effect of LIV versus wait- listed control upon muscle adipose infiltration measured by muscle density on peripheral quantitative CT imaging of the proximal and distal tibia and radius
5. To compare the effect of LIV versus wait-listed control on trabecular and cortical volumetric bone mineral density by high resolution peripheral quantitative CT of the distal and diaphyseal tibia and radius
6. To compare the effect of LIV versus wait- listed control on serologic markers of bone turnover, including TGF-beta and NTX
7. To compare the effect of LIV versus wait- listed controls upon patient reported outcome measures of fatigue (measured by the Basic Fatigue Inventory), muscle ache, and joint pain (measured by PRO-CTCAE)
8. To describe the feasibility of LIV in this patient population, defined by patient compliance and follow up with the intervention

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.

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

Peak power will be measured using the Power Protocol-B

A Biodex 4 system will be used to measure each subject's muscle contractile properties

Lean mass, total adiposity measured by DXA scan

Bone mineral density (T score) measured by DXA scan

By high resolution peripheral quantitative CT of the distal and diaphyseal tibia and radius

TGF-beta and NTX by quantitative measurements using ELISA

Average of all 9 items ranging in a score of 0-10 (total possible score of 11) scores range from 1( no fatigue/does not interfere) to 10 (as bad as you can imagine/completely interferes)

Average of 2 scale items for aching muscles and joint pain on a 5-point Likert scale (ranging in severity) with a total possible score of 5 (i.e. very severe/ almost constantly)

Patients will be asked by the study nurse how they are doing with their LIV therapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Effect of Low Intensity Vibration (LIV) on Aromatase Inhibitor- Induced Musculoskeletal Dysfunction in Early Stage Breast Cancer Survivors	NCT03712813	Breast Cancer	Macrodyne LivMD...	18 Years -	Indiana University
Effect of Low Intensity Vibration (LIV) on Aromatase Inhibitor- Induced Musculoskeletal Dysfunction in Early Stage Breast Cancer Survivors	NCT03712813	Breast Cancer	Macrodyne LivMD...	18 Years -	Indiana University

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