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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.
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
LOFT Therapyâ„¢ Summary LOFT Therapyâ„¢ is a form of exercise that requires less energy for movement. LOFT Therapyâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LOFT Therapy | Experimental | LOFT therapy twice weekly for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LOFT Therapy | Other | LOFT Therapyâ„¢ 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. |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathy Miller, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Health Hospital | Indianapolis | Indiana | 46202 | United States | ||
| Indiana University Melvin and Bren Simon Cancer Center |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| 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) |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| D017437 |
| Skin and Connective Tissue Diseases |