Impact of LOFT Therapy™ on Breast Cancer Survivors

NCT02491957 | Completed DMC

• 1 other identifier: IUSCC-0539
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Breast Neoplasms

Keywords

Energy Expenditure; Physical Endurance; Muscle Stength; Metabolism

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Safety of LOFT intervention in this population 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

  Change from pre-LOFT therapy (baseline) to post-LOFT therapy (5 weeks after baseline)

• Daily activity

  Change from pre-LOFT therapy (baseline) to post-LOFT therapy (5 weeks after baseline)

Study Arms (1)

LOFT Therapy

EXPERIMENTAL

LOFT therapy twice weekly for 4 weeks

Other: LOFT Therapy

Interventions

LOFT Therapy OTHER

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.

LOFT Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Kathy Miller: lead

Study Sites (2)

Indiana University Health Hospital

Indianapolis, Indiana, 46202, United States

Location

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Kathy Miller, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine and Sheila D. Ward Scholar

Study Record Dates

• First Submitted: June 2, 2015
• First Posted: July 8, 2015
• Study Start: July 28, 2015
• Primary Completion: March 29, 2018
• Study Completion: March 29, 2018
• Last Updated: August 13, 2018

Record last verified: 2018-08

Locations

US (2)