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NCT02491957 · ClinicalTrials.gov registry record · NA

Impact of LOFT Therapy™ on Breast Cancer Survivors

A NA study, sponsored by Kathy Miller.

Completed
Registry status
NA
Development phase
15
Enrollment target

NCT02491957: Completed NA study, sponsored by Kathy Miller.

NCT02491957 is a NA study that has completed, run by Kathy Miller. The registered enrollment target is 15 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02491957, a NA study, has completed, sponsored by Kathy Miller.

COMPLETED
Registry status
NA
Development phase
15 participants
Enrollment target

Study 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.

Primary Outcome

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

Interventions

  • OTHER LOFT Therapy

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2015-07-28
Est. Completion 2018-03-29
Phase NA
Kathy Miller

8 total trials

What the finished NCT02491957 record still lists

NCT02491957 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which LOFT Therapy is the first listed.

NCT02491957 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02491957 about?

NCT02491957 is a clinical study titled "Impact of LOFT Therapy™ on Breast Cancer Survivors". 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 effec...

What is the current status of trial NCT02491957?

This trial is currently completed. It is a NA study. The enrollment target is 15 participants. The study started on 2015-07-28. Estimated completion is 2018-03-29.

What interventions are being tested in trial NCT02491957?

The interventions under investigation include: LOFT Therapy (OTHER).

Who is sponsoring clinical trial NCT02491957?

This trial is sponsored by Kathy Miller, which has 8 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02491957's enrollment target sits among peer trials

15 1881st of 2000 higher than 92 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02491957, the US trial registry maintained by the National Library of Medicine. NCT02491957 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.