Impact of LOFT Therapy™ on Breast Cancer Survivors

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and feasibility of LOFT Therapy in breast cancer survivors. In a previous study, the investigators found that many patients are more debilitated at diagnosis than previously recognized. Both chemotherapy and anti-estrogen therapy have a large effect. Within 6 months patients replace muscle with fat leading to a significant reduction in muscle power and endurance. Our data suggests that common exercise recommendations for at least 150 minutes of exercise a week would be far beyond many of our patients' physical ability after therapy, leading to the soreness, injury, frustration, and early discontinuation (or failure to initiate an exercise program in the first place). The degree of muscle loss seen in our patients is similar to that documented in US astronauts after long-term space flight. Our collaborator Dr. Yvonne Cagle, retired USAF flight surgeon, noted that the cosmonauts were in better shape (had less muscle atrophy) than the astronauts. This difference was more than could be explained by the rigorous Russian exercise program. The only key distinction was the compressive, penguin suits used by the Russians. This observation lead Dr. Cagle to develop a technique called low intensity, off loaded-compressive therapy (LOFT) to replicate the impact of the Russian penguin suits for patients who were debilitated, whether by space flight or by chronic conditions such as arthritis, Parkinson's disease, and multiple sclerosis. The LOFT method does not require excessive exertion or strain on the joints. In field observations, LOFT therapy improved muscle strength, muscle mass, endurance, sleep quality, and fatigue. This pilot study is the first to evaluate the safety, feasibility, and biologic impact of LOFT on breast cancer survivors.

Detailed Description
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Objectives This pilot trial will provide feedback on the feasibility and impact of LOFT in breast cancer survivors. The investigators will also explore the relationship of the LOFT intervention to changes in insulin resistance, growth hormone levels, body mass index, patient reported physical activity, fatigue, and overall quality of life. Primary Objective Evaluate the safety and feasibility of LOFT training in breast cancer survivors (< 3 years from diagnosis) treated with either chemotherapy and/or anti-estrogen therapy. Secondary Objectives Estimate the effect size of LOFT training on muscle power, endurance, daily activity, fatigue, and quality of life. Estimate the effect of short-term LOFT training on biochemical parameters of inflammation, metabolism, anabolic hormone secretion, and bone turnover. LOFT Therapy™ Summary LOFT Therapy™ is a form of exercise that requires less energy for movement. LOFT Therapy™ will be performed 2 times a week for 4 weeks a total of 8 sessions. The patient will be wrapped with fabric cuffs, on up to four limbs. The cuffs are applied to the widest part of the biceps and upper thighs at pressures between 80-100 mmHg with minimal venous encroachment. The patients will ride a recumbent bike for 18 total minutes of sub-maximal exertion (up to 70% repetition maximum ), with the option of up to 2 periods of 15-second higher intensity exertions as tolerated, followed by individualized respiratory recovery periods determined by the relative decrease in breathing effort. The 18-minute session will be preceded by a two-minute compression check, where the wraps will be adjusted based on any signs or symptoms of nerve or vessel impingement. Patients will undergo an intake and outtake assessment with each session to collect subjective data and patient feedback. Two compression sessions will be conducted for 4 weeks, for a total of 8 sessions. This study will enroll 15 patients. A 20% dropout rate for this group was taken into consideration so the investigators assume analysis will be done on at least 12 patients.

Official Title
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Impact of LOFT Therapy™ on Breast Cancer Survivors: A Pilot Study

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Other: LOFT Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with stage 0-III breast cancer within the past 3 years Must have completed local therapy for their breast cancer Must have received systemic therapy for their breast cancer (anti-estrogen and/or chemotherapy) Chemotherapy must be complete prior to entry Anti-estrogen therapy may be ongoing Ambulatory without assistive devices No orthopedic restrictions or neurologic deficits that would limit ability to complete the Power Protocol (based on the opinion of the investigator) No requirement for supplemental O2 No unstable angina, regular use of nitroglycerin for exertional angina, or MI within the last 12 months No local or distant recurrence of their breast cancer No active lymphedema No history of hemorrhagic stroke No Heparin or Coumadin Use No symptomatic peripheral vascular obstructions No active gallbladder disease No active kidney stones No active gout No active diverticulitis No pituitary diseases or growth Able to provide written informed consent and authorization for release of health information Able to commit to LOFT training 2 times/week for 4 weeks Exclusion Criteria: Inability to meet one of the inclusion criteria above.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LOFT Therapy<br>LOFT therapy twice weekly for 4 weeks | Other: LOFT Therapy<br>* LOFT Therapy™ will be performed 2 times a week for 4 weeks a total of 8 sessions. The patient will be wrapped with fabric cuffs, on up to four limbs. The cuffs are applied to the widest part of the biceps and upper thighs at pressures between 80-100 mmHg with minimal venous encroachment. The patients will ride a recumbent bike for 18 total minutes of sub-maximal exertion (up to 70% repetition maximum ), with the option of up to 2 periods of 15-second higher intensity exertions as tolerated, followed by individualized respiratory recovery periods determined by the relative decrease in breathing effort. The 18-minute session will be preceded by a two-minute compression check, where the wraps will be adjusted based on any signs or symptoms of nerve or vessel impingement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of LOFT therapy in breast cancer survivors (< 3 years from diagnosis) treated with either chemotherapy and/or anti-estrogen therapy | Analysis of the modified intent-to-treat population defined as patients with at least 1 post-baseline measurement as well as eligible patients who decline participation, reason for refusal, and number of enrolled patients who do not complete all LOFT training sessions | Change from pre-LOFT therapy (baseline) to post-LOFT therapy (5 weeks after baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of LOFT intervention in this population patient reported adverse events | Assessed by patient reported adverse events | Assessed at each session and throughout the intervention | 
| Heart rate |  | Change from pre-LOFT therapy (baseline) to post-LOFT therapy (5 weeks after baseline) | 
| Power per body weight (muscle power) |  | Change from pre-LOFT therapy (baseline) to post-LOFT therapy (5 weeks after baseline) | 
| Endurance | Assessed by patient self-report | Change from pre-LOFT therapy (baseline) to post-LOFT therapy (5 weeks after baseline) | 
| Daily activity | Measured by Physical Activity Report questionnaire | Change from pre-LOFT therapy (baseline) to post-LOFT therapy (5 weeks after baseline) | 
| Fatigue | Measured by BFI questionnaire | Change from pre-LOFT therapy (baseline) to post-LOFT therapy (5 weeks after baseline) | 
| Quality of life | Measured by FACT-B questionnaire | Change from pre-LOFT therapy (baseline) to post-LOFT therapy (5 weeks after baseline) | 
| Biochemical parameters of chronic inflammation | Blood samples | Change from pre-LOFT therapy (baseline) to post-LOFT therapy (5 weeks after baseline) | 
| Biochemical parameters of metabolism and insulin homeostasis | Blood samples | Change from pre-LOFT therapy (baseline) to post-LOFT therapy (5 weeks after baseline) | 
| Anabolic hormone secretion | Blood samples | Change from pre-LOFT therapy (baseline) to post-LOFT therapy (5 weeks after baseline) | 
| Biochemical parameters of bone turnover | Blood samples | Change from pre-LOFT therapy (baseline) to post-LOFT therapy (5 weeks after baseline) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Energy Expenditure, Physical Endurance, Muscle Stength, Metabolism