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

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ClinicalTrials.gov Identifier: NCT03712813
Recruitment Status : Not yet recruiting
First Posted : October 19, 2018
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Tarah Ballinger, Indiana University

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Device: Macrodyne LivMD plate Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Supportive Care
Official Title: Effect of Low Intensity Vibration (LIV) on Aromatase Inhibitor- Induced Musculoskeletal Dysfunction in Early Stage Breast Cancer Survivors
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Macrodyne LivMD plate Device: Macrodyne LivMD plate
Synchronous (applied to both feet) low intensity vibration for 10 minutes, twice daily for 12 months.

No Intervention: Wait-Listed Control



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Change in muscle contractile properties including peak power, fatigue resistance, and time to recovery measured by isokinetic knee extension [ Time Frame: Baseline and 12 months ]
    A Biodex 4 system will be used to measure each subject's muscle contractile properties

  2. Change in lean body mass by DEXA scan [ Time Frame: Baseline and 12 months ]
  3. Change in bone mineral density of the lumbar spine by T score measured by DXA scan [ Time Frame: Baseline and 12 months ]
  4. Change in trabecular and cortical volumetric bone mineral density measured by high resolution peripheral quantitative CT [ Time Frame: Baseline and 12 months ]
  5. Change in serologic bone markers of bone turnover (TGF-beta and NTX) by quantitative measurements using ELISA [ Time Frame: Baseline and 12 months ]
  6. Patient reported fatigue measured by the Basic Fatigue Inventory score [ Time Frame: Baseline and 12 months ]
    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)

  7. 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 ]
    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)

  8. Feasibility of low intensity vibration defined by patient compliance [ Time Frame: Baseline and 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Post- menopausal and planned to initiate an AI

    1. Post- menopausal defined as ≥ 60 years of age, prior bilateral oophorectomy, or age ≥ 50 and absence of any menstrual periods in the last 12 months.
    2. Chemical ovarian suppression is not allowed.
    3. Prior use of a SERM and now switching to an AI is allowed.
  3. Diagnosis of DCIS or stage I, II, or III breast cancer
  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 is allowed. Neratinib, immunotherapy, or CDK4/6 inhibitor therapy is not allowed.
  5. Baseline T score > - 2.0 on DXA
  6. Body weight less than 275 lbs., as dictated by the weight limit for the LIV platforms
  7. ECOG performance status of 0-1 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 60 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 must be corrected to ≥ 20 ng/ml prior to study enrollment. History of vitamin D deficiency is allowed.

  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. Locally recurrent or 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.
  12. Women undergoing ovarian suppression with drug therapy are excluded

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03712813


Contacts
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Contact: Jessica L Sollars, RN 317-278-5117 jlsherma@iupui.edu
Contact: Tarah Ballinger, MD tarab@iu.edu

Sponsors and Collaborators
Indiana University
Investigators
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Principal Investigator: tarah Ballinger, MD Indiana University

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Responsible Party: Tarah Ballinger, Assistant Professor of Clinical Medicine, Indiana University
ClinicalTrials.gov Identifier: NCT03712813     History of Changes
Other Study ID Numbers: IUSCC-0680
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tarah Ballinger, Indiana University:
aromatase inhibitors
low intensity vibration

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs