Impact of LOFT Therapy™ on Breast Cancer Survivors

Completed · Not applicable

Conditions studied: Breast Neoplasms

In brief

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.

Key facts

Study ID

NCT02491957

Run by

Kathy Miller

People needed

15

Starts

2015-07-28

Expected to finish

2018-03-29

Last updated by the study team

2018-08-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Inability to meet one of the inclusion criteria above.

Where it is running

• Indiana University Health Hospital — Indianapolis, Indiana, United States
• Indiana University Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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