Clinical Trials /

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

NCT03712813

Description:

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.

Related Conditions:
  • Breast Carcinoma
  • Ductal Carcinoma In Situ
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: IUSCC-0680
  • NCT ID: NCT03712813

Conditions

  • Breast Cancer

Purpose

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

        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
    

Trial Arms

NameTypeDescriptionInterventions
Macrodyne LivMD plateExperimental
    Wait-Listed ControlNo Intervention

      Eligibility 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
            
      Maximum Eligible Age:N/A
      Minimum Eligible Age:18 Years
      Eligible Gender:All
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Mean change in energetic capacity measured by peak power generation on a stationary bicycle
      Time Frame:Baseline and 12 months
      Safety Issue:
      Description:Peak power will be measured using the Power Protocol-B

      Secondary Outcome Measures

      Measure: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
      Safety Issue:
      Description:A Biodex 4 system will be used to measure each subject's muscle contractile properties
      Measure:Change in lean body mass by DEXA scan
      Time Frame:Baseline and 12 months
      Safety Issue:
      Description:
      Measure:Change in bone mineral density of the lumbar spine by T score measured by DXA scan
      Time Frame:Baseline and 12 months
      Safety Issue:
      Description:
      Measure:Change in trabecular and cortical volumetric bone mineral density measured by high resolution peripheral quantitative CT
      Time Frame:Baseline and 12 months
      Safety Issue:
      Description:
      Measure:Change in serologic bone markers of bone turnover (TGF-beta and NTX) by quantitative measurements using ELISA
      Time Frame:Baseline and 12 months
      Safety Issue:
      Description:
      Measure:Patient reported fatigue measured by the Basic Fatigue Inventory score
      Time Frame:Baseline and 12 months
      Safety Issue:
      Description: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)
      Measure: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
      Safety Issue:
      Description: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)
      Measure:Feasibility of low intensity vibration defined by patient compliance
      Time Frame:Baseline and 12 months
      Safety Issue:
      Description:

      Details

      Phase:Phase 2
      Primary Purpose:Interventional
      Overall Status:Not yet recruiting
      Lead Sponsor:Indiana University

      Trial Keywords

      • aromatase inhibitors
      • low intensity vibration

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