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
Inclusion Criteria:
1. Age ≥ 18 years
2. Diagnosis of DCIS or stage I, II, or III breast cancer 3 Planned to initiate an AI
1. 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
2. Premenopausal patients receiving chemical ovarian suppression are allowed
3. Prior aromatase inhibitor use (if this is a second primary, for example) is
allowed as long as it has been more than 12 months
4. 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)
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. Neratinib, immunotherapy, or CDK4/6 inhibitor therapy is not 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:
1. Unwilling to co-enroll onto the companion FIT core study (IRB study #1707550885)
2. 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.
3. Prior history of non-traumatic, fragility bone fracture
4. Any muscle or neuromuscular disorder affecting muscle function, such as muscular
dystrophy, myositis, or amyotrophic lateral sclerosis
5. Use of bisphosphonates or denosumab within the prior 12 months
6. History of retinal detachment
7. Current or planned pacemaker
8. Current or planned cochlear implant
9. 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
10. 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.
11. Patients requiring chronic anticoagulation are excluded from participation in the
optional muscle biopsy collection.