What is the mechanism of action of this treatment?

Common treatments for breast cancer include surgery, chemotherapy, radiation therapy, hormone therapy, and targeted therapy. Surgery involves the physical removal of the tumor, which is crucial for eliminating cancerous cells from the body. Chemotherapy uses drugs to kill rapidly dividing cancer cells, while radiation therapy employs high-energy rays to destroy cancer cells in a specific area. Hormone therapy blocks hormones like estrogen that can promote the growth of certain types of breast cancer. Targeted therapy focuses on specific molecules involved in cancer growth and progression, such as HER2 proteins. These treatments are essential for reducing tumor size, preventing metastasis, and improving survival rates. In the context of Low Intensity Vibration (LIV) therapy, mechanical stimulation is used to enhance muscle function and energetic capacity, which can be particularly beneficial for patients experiencing musculoskeletal dysfunction due to cancer treatments like aromatase inhibitors.

What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as aromatase inhibitors, can lead to musculoskeletal side effects including joint pain, muscle pain, and decreased bone density. These treatments may also cause fatigue, hot flashes, and an increased risk of osteoporosis. Chemotherapy, another common treatment, can result in side effects like nausea, hair loss, fatigue, and neuropathy. Radiation therapy often leads to skin irritation and fatigue, while surgery can cause pain, swelling, and limited range of motion. Hormonal therapies may also contribute to mood swings and weight gain.

What prior FDA approvals exist?

There are no FDA-approved treatments for breast cancer that specifically involve mechanical stimulation like Low Intensity Vibration (LIV). However, FDA-approved treatments for breast cancer include a variety of hormonal therapies, chemotherapy agents, targeted therapies, and immunotherapies. Examples include aromatase inhibitors (such as letrozole and anastrozole), chemotherapy drugs (such as doxorubicin and paclitaxel), targeted therapies (such as trastuzumab for HER2-positive breast cancer), and immunotherapies (such as pembrolizumab). These treatments aim to reduce tumor size, prevent recurrence, and improve survival rates in breast cancer patients.

What other types of research exist?

Promising alternatives to Low Intensity Vibration (LIV) for breast cancer patients include Low-Level Laser Therapy (LLLT) and Photobiomodulation (PBM). These therapies have shown potential in reducing muscle fatigue and improving muscle performance by using light energy to stimulate cellular processes. They could be particularly beneficial for managing musculoskeletal dysfunction induced by aromatase inhibitors.

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Low Intensity Vibration for Breast Cancer Survivor Muscle Function

N/A

Recruiting

Led By tarah Ballinger, MD

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status of 0-2 at the time of study enrollment

Physically able to stand unassisted for 10 minutes at a time

Must not have

Prior history of non-traumatic, fragility bone fracture

History of retinal detachment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 months, and 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if gentle body vibrations can help improve muscle and bone health in early-stage breast cancer patients who are starting a specific therapy and don't exercise regularly. The vibrations are done for short periods each day.

Who is the study for?

This trial is for early stage breast cancer survivors who are about to start aromatase inhibitor therapy and don't regularly exercise. Participants should be post-menopausal or premenopausal with ovarian suppression, have a good performance status, weigh less than 275 lbs., able to stand unassisted for 10 minutes, and completed primary cancer treatments. Exclusions include severe heart conditions, muscle disorders, metastatic breast cancer, certain bone diseases, chronic renal disease or planned cochlear implant.

What is being tested?

The study tests the effects of Low Intensity Vibration (LIV) on muscle function in breast cancer survivors using a Macrodyne LivMD plate. Patients will use this device twice daily for ten minutes over twelve months while their muscle power output on a stationary bike is measured against those who wait-listed as controls.

What are the potential side effects?

While not explicitly stated in the provided information, potential side effects may include discomfort from standing on the vibration plate and fatigue from regular use. Any unexpected symptoms experienced during the trial would be monitored closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and am up and about more than 50% of my waking hours.

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I can stand by myself for 10 minutes.

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I am 18 years old or older.

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I have been diagnosed with early or locally advanced breast cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a bone break easily in the past without major injury.

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I have had a retinal detachment in the past.

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I have a muscle or nerve condition like muscular dystrophy.

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I have used bisphosphonates or denosumab in the last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 months, and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 months, and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 months, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean change in energetic capacity measured by peak power generation on a stationary bicycle

Secondary study objectives

Change in bone mineral density of the lumbar spine by T score

Change in lean body mass

Change in muscle contractile properties including peak power, fatigue resistance, and time to recovery measured by isokinetic knee extension

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Macrodyne LivMD plateExperimental Treatment1 Intervention

Group II: Wait-Listed ControlActive Control1 Intervention

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for breast cancer include surgery, chemotherapy, radiation therapy, hormone therapy, and targeted therapy. Surgery involves the physical removal of the tumor, which is crucial for eliminating cancerous cells from the body. Chemotherapy uses drugs to kill rapidly dividing cancer cells, while radiation therapy employs high-energy rays to destroy cancer cells in a specific area. Hormone therapy blocks hormones like estrogen that can promote the growth of certain types of breast cancer. Targeted therapy focuses on specific molecules involved in cancer growth and progression, such as HER2 proteins. These treatments are essential for reducing tumor size, preventing metastasis, and improving survival rates. In the context of Low Intensity Vibration (LIV) therapy, mechanical stimulation is used to enhance muscle function and energetic capacity, which can be particularly beneficial for patients experiencing musculoskeletal dysfunction due to cancer treatments like aromatase inhibitors.

Effects of whole-body vibration training in a cachectic C26 mouse model.The preventive effect of sensorimotor- and vibration exercises on the onset of Oxaliplatin- or vinca-alkaloid induced peripheral neuropathies - STOP.Effects of an aerobic exercise programme on fatigue for patients with breast cancer undergoing radiotherapy.