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
Study Type
INTERVENTIONAL
Allocation
Synchronous (applied to both feet) low intensity vibration for 10 minutes, twice daily for 12 months.
Indiana University Melvin & Bren Simon Cancer Center
Indianapolis, Indiana, United States
Mean change in energetic capacity measured by peak power generation on a stationary bicycle
Peak power will be measured using the Power Protocol-B
Time frame: Baseline and 12 months
Change in muscle contractile properties including peak power measured by isokinetic knee extension
A Biodex 4 system will be used to measure each subject's muscle contractile properties
Time frame: Baseline and 12 months
Change in muscle contractile properties including fatigue resistance measured by isokinetic knee extension
A Biodex 4 system will be used to measure each subject's muscle contractile properties
Time frame: Baseline and 12 months
Change in muscle contractile properties including time to recovery measured by isokinetic knee extension
A Biodex 4 system will be used to measure each subject's muscle contractile properties
Time frame: Baseline and 12 months
Change in lean body mass
Lean mass, total adiposity measured by DXA scan
Time frame: Baseline and 12 months
Change in bone mineral density of the lumbar spine by T score
Bone mineral density (T score) measured by DXA scan
Time frame: Baseline and 12 months
Change in cortical volumetric bone mineral density
By high resolution peripheral quantitative CT of the distal and diaphyseal tibia and radius
Time frame: Baseline and 12 months
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RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
72
Change in trabecular volumetric bone mineral density
By high resolution peripheral quantitative CT of the distal and diaphyseal tibia and radius
Time frame: Baseline and 12 months
Change in serologic bone markers of bone turnover (TGF-beta) by quantitative measurements using ELISA
TGF-beta and NTX by quantitative measurements using ELISA
Time frame: Baseline and 12 months
Change in serologic bone markers of bone turnover (NTX) by quantitative measurements using ELISA
TGF-beta and NTX by quantitative measurements using ELISA
Time frame: Baseline and 12 months
Patient reported fatigue measured by the Basic Fatigue Inventory score
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)
Time frame: Baseline 12 months
Patient reported aching muscles and joint pain measured by NCI Patient Reported Outcomes-Common Terminology Criteria for Adverse Events score
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)
Time frame: Baseline and 12 months
Feasibility of low intensity vibration defined by patient compliance
Patients will be asked by the study nurse how they are doing with their LIV therapy
Time frame: Once monthly from Baseline to 12 months