Breast CancerNCT03712813
Effect of Low Intensity Vibration (LIV) on Aromatase Inhibitor- Induced Musculoskeletal Dysfunction in Early Stage Breast Cancer Survivors
A study testing Macrodyne LivMD plate in people with Breast Cancer, run by Indiana University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Macrodyne LivMD plate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2019to 18 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Diagnosis of DCIS or stage I, II, or III breast cancer 3 Planned to initiate an AI
- 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
- Premenopausal patients receiving chemical ovarian suppression are allowed
- Prior aromatase inhibitor use (if this is a second primary, for example) is allowed as long as it has been more than 12 months
- 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. 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)
Who cannot join
- 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)
- 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
Show all 13Show fewer
- 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
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Melvin & Bren Simon Cancer Center
Indianapolis, Indiana, 46202
About this study
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.
Read the 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
- 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
- To compare the effect of LIV versus wait- listed control upon body composition (lean mass, total adiposity) measured by DXA scan
- To compare the effect of LIV versus wait- listed control upon bone mineral density (T score) measured by DXA scan
- 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
- 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
- To compare the effect of LIV versus wait- listed control on serologic markers of bone turnover, including TGF-beta and NTX
- 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)
- To describe the feasibility of LIV in this patient population, defined by patient compliance and follow up with the intervention
- Conditions
- Breast Cancer
- Being tested
- Macrodyne LivMD plate
- Keywords
- aromatase inhibitors, low intensity vibration
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macrodyne LivMD plateDevice
Synchronous (applied to both feet) low intensity vibration for 10 minutes, twice daily for 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Macrodyne LivMD plate | Experimental | Not described Receives: Device: Macrodyne LivMD plate |
| Wait-Listed Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in energetic capacity measured by peak power generation on a stationary bicycle
Peak power will be measured using the Power Protocol-B
Measured: Baseline and 12 months
Secondary outcomes (12)
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
Measured: 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
Measured: 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
Measured: Baseline and 12 months
Change in lean body mass
Lean mass, total adiposity measured by DXA scan
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: Once monthly from Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start2 Oct 2019
- Primary completion18 Dec 2025
- Study completion18 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarah J Ballinger, MD, Indiana University
- Investigators
- Tarah Ballinger, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03712813
- Sponsor's protocol ID
- IUSCC-0680
- Status last verified
- May 2026
- First submitted
- 16 Oct 2018
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low Intensity Vibration (LIV) on Aromatase Inhibitor- Induced Musculoskeletal Dysfunction in Early Stage Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT03712813
- Acronym / sponsor ID
- IUSCC-0680
- Conditions
- Breast Cancer
- Keywords
- aromatase inhibitors, low intensity vibration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 2 Oct 2019 (actual)
- Primary completion
- 18 Dec 2025 (actual)
- Study completion
- 18 Dec 2025 (actual)
- First posted
- 19 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
- To compare the effect of LIV versus wait- listed control upon body composition (lean mass, total adiposity) measured by DXA scan
- To compare the effect of LIV versus wait- listed control upon bone mineral density (T score) measured by DXA scan
- 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
- 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
- To compare the effect of LIV versus wait- listed control on serologic markers of bone turnover, including TGF-beta and NTX
- 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)
- To describe the feasibility of LIV in this patient population, defined by patient compliance and follow up with the intervention
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Macrodyne LivMD plate | Experimental | Device: Macrodyne LivMD plate |
| Wait-Listed Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (13 listed)
- 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)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Macrodyne LivMD plateSynchronous (applied to both feet) low intensity vibration for 10 minutes, twice daily for 12 months. | Device | Macrodyne LivMD plate |
Primary outcome
Mean change in energetic capacity measured by peak power generation on a stationary bicycle
Time frame: Baseline and 12 months
Peak power will be measured using the Power Protocol-B
12 secondary outcomes
Change in muscle contractile properties including peak power measured by isokinetic knee extension
Time frame: Baseline and 12 months
Change in muscle contractile properties including fatigue resistance measured by isokinetic knee extension
Time frame: Baseline and 12 months
Change in muscle contractile properties including time to recovery measured by isokinetic knee extension
Time frame: Baseline and 12 months
Change in lean body mass
Time frame: Baseline and 12 months
Change in bone mineral density of the lumbar spine by T score
Time frame: Baseline and 12 months
Change in cortical volumetric bone mineral density
Time frame: Baseline and 12 months
Change in trabecular volumetric bone mineral density
Time frame: Baseline and 12 months
Change in serologic bone markers of bone turnover (TGF-beta) 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
Time frame: Baseline and 12 months
Patient reported fatigue measured by the Basic Fatigue Inventory score
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
Time frame: Baseline and 12 months
Feasibility of low intensity vibration defined by patient compliance
Time frame: Once monthly from Baseline to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tarah Ballinger, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Macrodyne LivMD plate in people with Breast Cancer, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in energetic capacity measured by peak power generation on a stationary bicycle (time frame: Baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.