NCT03712813

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	Macrodyne LivMD plate	Synchronous (applied to both feet) low intensity vibration for 10 minutes, twice daily for 12 months.

Timeline

• Start date: 2019-10-02
• Primary completion: 2025-12-18
• Completion: 2025-12-18
• First posted: 2018-10-19
• Last updated: 2026-02-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study