Breast NeoplasmsNCT02491957
Impact of LOFT Therapy™ on Breast Cancer Survivors
A study testing LOFT Therapy in people with Breast Neoplasms, run by Kathy Miller at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- LOFT Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Jul 2015to 29 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 21Show fewer
- 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
Who cannot join
- Inability to meet one of the inclusion criteria above.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Indiana University Health Hospital
Indianapolis, Indiana, 46202
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
About this study
Official title: Impact of LOFT Therapy™ on Breast Cancer Survivors: A Pilot Study
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.
Read the detailed description
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.
- Conditions
- Breast Neoplasms
- Being tested
- LOFT Therapy
- Keywords
- Energy Expenditure, Physical Endurance, Muscle Stength, Metabolism
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LOFT TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| LOFT Therapy | Experimental | LOFT therapy twice weekly for 4 weeks Receives: Other: LOFT Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 by patient reported adverse events
Measured: Assessed at each session and throughout the intervention
Heart rate
Measured: Change from pre-LOFT therapy (baseline) to post-LOFT therapy (5 weeks after baseline)
Power per body weight (muscle power)
Measured: Change from pre-LOFT therapy (baseline) to post-LOFT therapy (5 weeks after baseline)
Endurance
Assessed by patient self-report
Measured: Change from pre-LOFT therapy (baseline) to post-LOFT therapy (5 weeks after baseline)
Daily activity
Measured by Physical Activity Report questionnaire
Measured: Change from pre-LOFT therapy (baseline) to post-LOFT therapy (5 weeks after baseline)
Fatigue
Measured by BFI questionnaire
Measured: Change from pre-LOFT therapy (baseline) to post-LOFT therapy (5 weeks after baseline)
Quality of life
Measured by FACT-B questionnaire
Measured: Change from pre-LOFT therapy (baseline) to post-LOFT therapy (5 weeks after baseline)
Biochemical parameters of chronic inflammation
Blood samples
Measured: Change from pre-LOFT therapy (baseline) to post-LOFT therapy (5 weeks after baseline)
Biochemical parameters of metabolism and insulin homeostasis
Blood samples
Measured: Change from pre-LOFT therapy (baseline) to post-LOFT therapy (5 weeks after baseline)
Anabolic hormone secretion
Blood samples
Measured: Change from pre-LOFT therapy (baseline) to post-LOFT therapy (5 weeks after baseline)
Biochemical parameters of bone turnover
Blood samples
Measured: Change from pre-LOFT therapy (baseline) to post-LOFT therapy (5 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study start28 Jul 2015
- Primary completion29 Mar 2018
- Study completion29 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kathy Miller
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kathy Miller, Indiana University
- Investigators
- Kathy Miller, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02491957
- Sponsor's protocol ID
- IUSCC-0539
- Status last verified
- Aug 2018
- First submitted
- 2 Jun 2015
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of LOFT Therapy™ on Breast Cancer Survivors: A Pilot Study
- ClinicalTrials.gov ID
- NCT02491957
- Acronym / sponsor ID
- IUSCC-0539
- Conditions
- Breast Neoplasms
- Keywords
- Energy Expenditure, Physical Endurance, Muscle Stength, Metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Kathy MillerUniversity, hospital or other
- Study start
- 28 Jul 2015 (actual)
- Primary completion
- 29 Mar 2018 (actual)
- Study completion
- 29 Mar 2018 (actual)
- First posted
- 8 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LOFT Therapy | Experimental | Other: LOFT TherapyLOFT therapy twice weekly for 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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
Key exclusion criteria (1 listed)
- Inability to meet one of the inclusion criteria above.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LOFT TherapyLOFT 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. | Other | LOFT Therapy |
Primary outcome
Feasibility of LOFT therapy in breast cancer survivors (< 3 years from diagnosis) treated with either chemotherapy and/or anti-estrogen therapy
Time frame: Change from pre-LOFT therapy (baseline) to post-LOFT therapy (5 weeks after baseline)
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
11 secondary outcomes
Safety of LOFT intervention in this population patient reported adverse events
Time frame: Assessed at each session and throughout the intervention
Heart rate
Time frame: Change from pre-LOFT therapy (baseline) to post-LOFT therapy (5 weeks after baseline)
Power per body weight (muscle power)
Time frame: Change from pre-LOFT therapy (baseline) to post-LOFT therapy (5 weeks after baseline)
Endurance
Time frame: Change from pre-LOFT therapy (baseline) to post-LOFT therapy (5 weeks after baseline)
Daily activity
Time frame: Change from pre-LOFT therapy (baseline) to post-LOFT therapy (5 weeks after baseline)
Fatigue
Time frame: Change from pre-LOFT therapy (baseline) to post-LOFT therapy (5 weeks after baseline)
Quality of life
Time frame: Change from pre-LOFT therapy (baseline) to post-LOFT therapy (5 weeks after baseline)
Biochemical parameters of chronic inflammation
Time frame: Change from pre-LOFT therapy (baseline) to post-LOFT therapy (5 weeks after baseline)
Biochemical parameters of metabolism and insulin homeostasis
Time frame: Change from pre-LOFT therapy (baseline) to post-LOFT therapy (5 weeks after baseline)
Anabolic hormone secretion
Time frame: Change from pre-LOFT therapy (baseline) to post-LOFT therapy (5 weeks after baseline)
Biochemical parameters of bone turnover
Time frame: Change from pre-LOFT therapy (baseline) to post-LOFT therapy (5 weeks after baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathy Miller, MD principal investigator
Indiana University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LOFT Therapy in people with Breast Neoplasms, run by Kathy Miller at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of LOFT therapy in breast cancer survivors (< 3 years from diagnosis) treated with either chemotherapy and/or anti-estrogen therapy (time frame: Change from pre-LOFT therapy (baseline) to post-LOFT therapy (5 weeks after baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2018.