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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Macrodyne LivMD plate | Experimental |
| |
| Wait-Listed Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Macrodyne LivMD plate | Device | Synchronous (applied to both feet) low intensity vibration for 10 minutes, twice daily for 12 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline and 12 months |
| Change in muscle contractile properties including fatigue resistance measured by isokinetic knee extension |
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Inclusion Criteria:
Age ≥ 18 years
Diagnosis of DCIS or stage I, II, or III breast cancer 3 Planned to initiate an AI
4. 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.
5. 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)
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Tarah Ballinger, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Melvin & Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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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.
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A Biodex 4 system will be used to measure each subject's muscle contractile properties |
| 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 | Baseline and 12 months |
| Change in lean body mass | Lean mass, total adiposity measured by DXA scan | 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 | 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 | Baseline and 12 months |
| Change in trabecular volumetric bone mineral density | By high resolution peripheral quantitative CT of the distal and diaphyseal tibia and radius | 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 | 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 | 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) | 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) | 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 | Once monthly from Baseline to 12 months |
| D017437 |
| Skin and Connective Tissue Diseases |