Neoplasms

Digestive System Diseases

All Conditions

Nutritional and Metabolic Diseases

Symptoms and General Pathology

Rare Diseases

Esophageal Neoplasms

Adenocarcinoma

Wasting Syndrome

Cachexia

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Body Weight

Weight Loss

Body Weight Changes

Thinness

Esophageal Cancer

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

patients with esophageal or gastroesophageal adenocarcinoma included to evaluate the energy expenditure before and after chemotherapy and evaluate parameters of cachexia

During the 2 surgical time, when patient is under general anesthesia, two adipose tissue biopsies of 20cc each (one from abdominal subcutaneous adipose tissue and one from omental adipose tissue) are taken and characterize by oxygraphy (respirometry).

Before the 2 surgical times (before and after chemotherapy) patients will have evaluation of the muscle strength, cachexia (by scan analysis), energy expenditure, anthropometric criteria and biochemical inflammatory.

Adipose tissue biopsies

Lise LACLAUTRE

Ruddy RICHARD

Cachexia is a syndrome frequently associated with digestive cancers and more particularly with esophageal and gastroesophageal adenocarcinoma. Its pathophysiology remains poorly understood, multi-factorial, but strongly correlated to the prognosis of patients. It's a consequence of the imbalance of energy balance linked to tumoral process, to dysphagia and to anorexia, frequently present in these cancers. At the center of this imbalance, adipose tissue plays a major role. Recent studies showing that the mobilization of lipid substrates and the hypermetabolism of adipocytes are involving in its development, even before loss of muscle. As part of the management, neoadjuvant chemotherapy is usually administered with the main objective to reduce tumor extension and dissemination through actions on DNA and mitosis. These treatments will also alter the mitochondrial function of cells in other tissues, probably including that of adipocytes. A paradoxical effect on the cachectic process could thus be envisaged, as a decrease in mitochondrial activity and associated hypermetabolism, and therefore a preservation of fat mass, and by extension of muscle mass.

Primary endpoint: identify the adipocyte factors involved in the energy imbalance associated with the cachectic process in patients managed for esophageal or gastroesophageal adenocarcinoma.

Secondary endpoint: compare the results obtained before and after chemotherapy treatment according to the cachectic state and the anatomical location of the adipose sample (subcutaneous versus visceral) to evaluate the resting energy expenditure.

Two operative steps, separated by neoadjuvant chemotherapy, are classically planned in the management of esophageal and gastroesophageal adenocarcinoma: an exploratory laparoscopy as part of the disease extension assessment and the tumor resection surgery (esophagectomy). During these operations, the surgeon will perform a subcutaneous fat biopsy at the surgical approach and a visceral fat biopsy at the epiploic level. A portion of the samples will be immediately analyzed by high-resolution oxygraphy to evaluate the mitochondrial metabolism of the adipocytes. The rest of biopsies will be frozen for further biological analysis (enzymology, Western-blot, RT-qPCR) or embedded in paraffin for histological analysis (morphometry, inflammation, metabolism). Serum will also be recovered with the biopsies for specific biological analysis (inflammatory and lipid status).

In days preceding the interventions, in addition to the usual management, will be performed: an evaluation of the energy expenditure by indirect calorimetry, an evaluation of the body composition by Dual Energy X-ray Absorptiometry (DEXA), physical tests to evaluate sarcopenia and cachexia, nutritional and quality of life questionnaires, and a medical examination with a dietetic consultation.

patient undergoing surgery for esophageal adenocarcinoma or for gastroesophageal adenocarcinoma

Chemotherapy in the Context of Esophageal and Gastroesophageal Junction Cancer Cachexia

Effect of Chemotherapy on Metabolic Flexibility in the Context of Cachexia in Cancers of the Esophagus and Gastroesophageal Junction

Evaluation of mitochondrial respiration on adipose tissue before and after chemotherapy Mitochondrial respiration measurements in oxydo-phosphorylated conditions. For each patient measurements using ADP and carbohydrate or lipid substrates of the respiratory chain complexes for both the subcutaneous and the visceral tissue.

level of sarcopenia between 0 to 12 including 5 questions

Université d'Auvergne

CRNH Auvergne

Ligue contre le cancer, France

University Hospital, Clermont-Ferrand

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Syndrome

Obesity

Polycystic Ovary Syndrome

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Chronic Graft Versus Host Disease

Micronutrients

Urological Agents

Vitamins

Ascorbic Acid

Adrenergic Agents

Mirabegron

Adrenergic Agonists

Adrenergic beta-3 Receptor Agonists

Adrenergic beta-Agonists

Neurotransmitter Agents

Vitamin C

Women will take 100mg daily for 4 weeks. Men will take 200mg daily for 4 weeks. The medication is available in 50 mg tablets.

Males will be randomized to take placebo versus active drug (mirabegron). Those taking placebo will take 4 tablets each day to mirror to active group (taking 4 tablets of 50 mg each).

B Complex Plus Vitamin C Tablets

Ashley M Schmitz, C.R.N.P.

Aaron M Cypess, M.D.

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

Background:

Brown adipose tissue (BAT) is a type of fat in the body. It may prevent weight gain, improve insulin sensitivity, and reduce fatty liver. Researchers want to see if BAT helps the body burn energy.

Objective:

To learn more about how BAT works to burn energy.

Eligibility:

People ages 18-40 with a body mass index between 18 and 40

Design:

Participants will be screened with:

Medical history

Physical exam

Blood, urine, and heart tests

Dietitian interview

Participants will have an overnight baseline visit. This includes:

Repeats of screening tests

Exercise test

Scans. For one scan, a radioactive substance is injected into the arm.

FSIVGIT: An IV is inserted into veins in the right and left arms. Glucose and insulin are injected in one arm. Blood glucose and insulin levels are measured from the other.

Metabolic suite: Participants stay 18 19 hours in a room that measures their metabolic rate. Monitors on the body measure heart rate, movement, and temperature.

Optional fat biopsy: A small piece of tissue is removed with a needle.

Participants will take 2-4 pills daily for 4 weeks. All women will take the drug mirabegron. Men will be randomly get either the drug or a placebo.

All participants will have a visit after 2 weeks of the pills. They will repeat the screening tests.

Participants will have an overnight visit 2 weeks later. They will repeat the baseline tests.

Participants will keep food and medication diaries.

Participants will have a follow-up visit 2 weeks after stopping the pills. This includes heart tests.

Background issues and controversies

More than ever before, there is a rise in the rates of obesity and diabetes. As opposed to white fat which stores excess calories, brown fat - also known as brown adipose tissue or BAT - consumes this energy to generate heat. In settings of increased food consumption and cold-exposure, studies show that human BAT becomes more active, potentially combatting weight gain. Other emerging evidence indicates that human BAT may be an endocrine organ, releasing hormones into the blood and regulating other organs like skeletal muscle, liver, and the insulin-releasing pancreatic Beta-cell. However, alongside these promising studies are those people who believe that there is not enough BAT in humans to be functionally relevant, and it contributes little to heat generation or overall health.

Purpose/Rationale of the proposed study

One of the principal reasons for skepticism about the ability to utilize human BAT is that there is not very much compared to smaller animals in which BAT activation has shown such promise. Therefore, a critical step is to develop medicines that can grow BAT in people and evaluate what kind of health benefits can be achieved.

Specific objectives

This study will administer the clinically-available beta3-AR agonist, mirabegron (Myrbetriq(R), Astellas Pharma). We will determine whether we can increase BAT volume and activity in people after they have taken this medication daily for four weeks. Our current goal is to see if chronic administration of mirabegron leads to an increase in BAT volume and metabolic activity and if it produces health benefits.

Key elements of what is involved

At the beginning of the study, the participants will undergo a series of tests to determine their baseline amounts of BAT, blood sugar status, and levels of specified hormones. The testing will take place over the course of two to three days while an inpatient on the Metabolic Patient Care Unit at the NIH Clinical Center. Depending on the Cohort, participants will then take the medication alone for four weeks or both the medication and placebo for four weeks each, during which time they will continue their standard daily routines. At two weeks after starting placebo or mirabegron, participants will return for one day for the assessment of any interim changes and to validate safety. At the end of each set of four weeks there will be a second set of inpatient testing over two to three days. Participants will be brought back two weeks after finishing the study for a follow-up safety visit, at which time they will receive an ECG and heart rate monitoring.

Primary outcomes

The primary outcome is either the change in BAT metabolic activity as measured by 18FFDG PET/CT or glucose infusion rate as measured by a hyperinsulinemic euglycemic clamp. Secondary endpoints will examine multiple other factors, including body weight, fat mass, glucose tolerance, changes in levels of hormones, and improved liver function.

The Physiological Responses and Adaptation of Brown Adipose Tissue to Chronic Treatment With Beta3-Adrenergic Receptor Agonists

.Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures and appendices).

Change in brown adipose tissue (BAT) metabolic activity as measured by 18FFDG PET/CT

Change in glucose infusion rate, as measured by the hyperinsulinemic euglycemic clamp

Change in metabolic health parameters including body weight, fat mass, glucose tolerance, changes in levels of hormones, and improved liver function

Changes in glucose infusion rate, as measured by the hyperinsulinemic euglycemic clamp

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Facies

Q-NRG®

Clinicians need to measure energy expenditure (EE) by indirect calorimetry (IC) to optimize nutritional support for a better clinical outcome, especially in patients with chronic conditions or with high risk of under- and over- feeding. However, IC is rarely used in clinical routine because the devices currently on the market are of tedious use, imprecise and expensive. An easy-to-use, accurate and inexpensive IC device (Q-NRG® CE marking n°MED 9811) has been developed to meet specifications made by and for clinicians. The ease of use of this new IC device has been first evaluated in mechanical ventilation mode. This second phase aims at evaluating the ease of use, the stability and the feasibility of the measurements with this new IC device in canopy and face mask modes for spontaneously breathing adult patients.

This study aims at evaluating the ease of use, the stability and the feasibility of EE measurements with the new IC device in spontaneously breathing adult patients with malnutrition, cancer, surgery or haemodialysis, using the canopy and face mask modes.

Patient data will be obtained from the medical records before EE measurement. EE measurement will be performed sequentially with the Q-NRG® and the IC device currently used in each study center. Patient data input, calibration, installation of face mask or canopy hood on the patient, and EE measurement recording will be performed according to the procedure stated in their respective user manual. Time needed to perform EE will be calculated afterwards from the time the IC device is turned on to EE measurement reaches a steady state with a variation ≤10%.

In a subset of 15 subjects, accuracy of gas composition (O2 and CO2) measurement by the Q-NRG® will be assessed by comparison with the reference method consisting in a mass spectrometer.

The ICALIC 2 International Multicentric Study

Clinical Evaluation of the Ease of Use of a New Indirect Calorimeter in Canopy and Face Mask Modes for Energy Expenditure Measurement: The ICALIC 2 International Multicentric Study (Second Phase)

Accuracy of gas composition (O2 and CO2) measurement by the Q-NRG® assessed by comparison with a mass spectrometer.

Time needed to perform EE will be calculated from the time the Q-NRG® or the currently used calorimeter is turned on to EE measurement reaches a steady state with a variation ≤10%.

Accuracy and precision of VO2, VCO2, RQ and EE measurements with the Q-NRG® in face mask or canopy mode will be compared to currently used indirect calorimeters.

The stability of VO2, VCO2, RQ and EE measurements with the Q-NRG® in face mask or canopy mode will be compared to currently used indirect calorimeters.

Clinical conditions, if any, precluding or disturbing the EE measurement with the Q-NRG®.

Prof. Claude Pichard

Head, Clinical Nutrition

Musculoskeletal Diseases

Nervous System Diseases

Craniopharyngioma

Adamantinoma

Hypothalamic Neoplasms

Overweight

Overnutrition

Nutrition Disorders

Hypothalamic Obesity

Gastrointestinal Agents

Hypoglycemic Agents

Anti-Obesity Agents

Glucagon

Glucagon-Like Peptide 1

Exenatide

Glucagon-Like Peptide-1 Receptor Agonists

Incretins

Hormones

Hormone Antagonists

Injections of glucagon-like peptide (GLP)-1 agonist exenatide once weekly extended-release (Bydureon®) for 36 weeks in randomized intervention followed by 18 weeks open label exenatide once weekly extended-release.

Weekly injections of placebo for 36 weeks followed by 18 weeks open label exenatide once weekly extended-release.

placebo

Christian Roth, MD

The proposed multicenter study will test the effect of glucagon-like peptide (GLP)-1 agonist exenatide once weekly extended-release (ExQW, Bydureon®) on clinical outcomes and metabolic parameters in a double-blind, placebo-controlled 36 week randomized trial with an 18 week open label extension. Following baseline testing, 48 patients will be randomly assigned with equal allocation to ExQW or matching placebo injection for 36 weeks, followed by an 18 week open label extension during which all patients receive ExQW. Changes of weight status, body composition, free-living total daily energy expenditure (EE) by doubly labeled water (DLW), activity by acetimetry, energy intake (questionnaires and food diary), as well as glucose tolerance and hormonal parameters of energy homeostasis and insulin resistance will be assessed before treatment and at the end of the placebo-controlled phase (week 36). Activity, metabolic outcomes, energy intake will be also assessed at study week 18 (mid treatment of randomized study), as well as week 54 (end of open label treatment).

Excessive weight gain and its cardiometabolic sequela are frequent complications of hypothalamic tumors, a condition known as hypothalamic obesity (HO). Most tumors in this region are craniopharyngiomas (CP),1 which constitute 5-9% of childhood brain tumors. Patients with CP typically become obese and have more features of the metabolic syndrome compared to matched controls. Overall, a 3-19-fold higher cardiovascular mortality had been reported, and a recent nationwide population-based study in Sweden demonstrated increased rates for cerebral infarction (7-fold), death due to cerebrovascular diseases (5-fold), and type 2 diabetes mellitus (6-fold) in CP patients in comparison to the general population. Thus, early and effective management of obesity is vital for this population, which is more resistant to treatment than uncomplicated obesity. Recognized risk factors for severe obesity include large hypothalamic tumors or lesions affecting several medial and posterior hypothalamic nuclei that impact satiety signaling pathways. Structural damage in these nuclei often lead to uncontrolled appetite, rapid weight gain, central insulin and leptin resistance, decreased sympathetic activity, low energy expenditure (EE), and increased energy storage in adipose tissue. Recently, the investigators developed a semi-quantitative assessment of hypothalamic damage on brain magnetic resonance imaging (MRI) to predict the risk for HO development in CP.

Previous results of treating HO with a glucagon-like-peptide-1 receptor agonist (GLP1RA) in rats and humans provide promising proof-of-principle data to support this current randomized clinical trial. The primary hypothesis of this study is that drugs causing weight loss via intact hindbrain signaling pathways offer a desperately needed option for treatment of HO, even in very obese HO subjects with severe hypothalamic damage. Induction of weight loss by GLP1RAs is believed to be related to multiple mechanisms involving the gastrointestinal tract, vagus nerve, and the brain leading to increased satiety. Peripheral administration of GLP-1 or GLP1RA reduces blood glucose and energy intake in humans and rodents, and long-term treatment results in loss of body weight. Critically, the investigators do not know whether GLP1RA treatment affects EE and activity, or whether the site and size of brain lesions affect responses to GLP1RA treatment.

The investigators' previous clinical studies of the GLP1RA exenatide in obese adolescents and adults have generated the critical safety and efficacy data needed to design a clinical trial. In a pilot study conducted at Children's Hospitals and Clinics of MN, pretreatment hyperphagia was associated with BMI reduction. Using these data, the investigators have designed a prospective, multicenter trial that will examine the effects of GLP1RA on BMI, cardiovascular disease (CVD) risk factors, energy homeostasis and other factors in subjects with HO secondary to CP.

Energy Balance & Weight Loss in Craniopharyngioma-related or Other Hypothalamic Tumors in Hypothalamic Obesity

Glucagon-Like Peptide-1 Agonist Effects on Energy Balance in Hypothalamic Obesity

Percent change of body mass index (BMI), as calculated by the formula: body weight in kg divided by height in meters², between baseline and the end of the 36-week randomized drug treatment phase.

Body composition change between baseline and the end of the 36-week randomized drug treatment phase assessed by dual energy x-ray absorptiometry (DEXA) and expressed as the change in adipose tissue mass.

Changes in fat and total calorie intake during free buffet meals assessed at baseline and after 36-weeks of study drug treatment.

The buffet meal is an objective measure of satiety as it assesses food intake and choice after a caloric preload. A standardized test meal preload provided 20% of estimated daily caloric requirements,based on the Schofield-HW equation. The purpose of the test meal is to ensure that study participants are in an equally fed state. Ninety minutes later, an ad libitum buffet meal was served consisting of a wide variety of food items and more than the child's estimated daily calorie requirements will be offered (5,000 kcal). Children had access to the buffet for 30 min, after which calorie intake and composition of consumed foods was measured by weighing back uneaten food.

Change in fasting blood glucose between baseline and the end of the 36-week randomized drug treatment phase.

Change in fasting HDL cholesterol and triglycerides between baseline and the end of the 36-week randomized drug treatment phase.

Change in C-reactive protein (CRP) between baseline and the end of the 36-week randomized drug treatment phase.

Changes of insulin resistance estimated by the homeostasis model assessment of insulin resistance (HOMA-IR) using the formula HOMA-IR = insulin \[mU/l\] x glucose \[mmol/l\]) / 22.5 where both insulin and glucose values are obtained from a fasting blood sample.

Change in circulating leptin between baseline and the end of the 36-week randomized drug treatment phase.

Total energy expenditure in the free-living environment was measured using doubly labeled water which estimates carbon dioxide production by measuring the elimination of the tracers deuterium (²H) and oxygen-18 (¹⁸O) from the body. These measures are used to determine the average daily rate of carbon dioxide production which is then used to calculate total energy expenditure using an equation from Weir and an assumed food quotient (0.85).

Self-reported daily energy intake was assessed by Automated Self-Administered 24-Hour Dietary Recall (ASA24-Kids, http://appliedresearch.cancer.gov/tools/instruments/asa24/), a web-based diet assessment tool that allows 24-hour diet recall using branded food items.

Change in blood glucose measures 120 minutes post-glucose bolus during an oral glucose tolerance test between baseline and the end of the 36-week randomized drug treatment phase.

Children's Hospitals and Clinics of Minnesota

Vanderbilt University

Seattle Children's Hospital

Professor

Injections of glucagon-like peptide (GLP)-1 agonist exenatide once weekly extended-release (Bydureon®) for 36 weeks in randomized intervention

Exenatide: Weekly injections of active drug.

Double-Blind Exenatide Once Weekly Extended-release

Weekly injections of placebo for 36 weeks in randomized intervention

placebo: Weekly placebo injections

Double-Blind Placebo

18 weeks open label exenatide once weekly extended-release (Bydureon®) arm.

Exenatide: Weekly injections of active drug.

Open Label Exenatide Once Weekly Extended-release

Injections of glucagon-like peptide (GLP)-1 agonist exenatide once weekly extended-release (Bydureon®) for 36 weeks in randomized intervention followed by 18 weeks open label exenatide once weekly extended-release.

Exenatide: Weekly injections of active drug.

Exenatide Once Weekly Extended-release

Weekly injections of placebo for 36 weeks followed by 18 weeks open label exenatide once weekly extended-release.

placebo: Weekly placebo injections

Matching Placebo

Total

One participant withdrawn in placebo group

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Calculated by the formula: body weight in kg divided by height in meters².

Body Mass Index

Christian L. Roth, MD

Analyses include all participants randomized to a study drug and received at least one drug treatment administration. Missing data was imputed using a last observation carry-forward approach.

Percent Change of Body Mass Index (BMI) as Calculated by the Formula: Body Weight in kg Divided by Height in Meters².

Of the 41 enrolled participants, 20 out of 23 participants randomized to exenatide once weekly extended-release and 15 out of 18 participants randomized to placebo completed both pre- and post-treatment assessments and are included in this analysis.

Changes in Body Composition as Assessed by Body Fat Mass Using Dual Energy X-ray Absorptiometry (DEXA)

Fat Intake

Total Calorie Intake

Of the 41 enrolled participants, 18 out of 23 participants randomized to exenatide once weekly extended-release and 15 out of 18 participants randomized to placebo completed both pre- and post-treatment assessments and are included in this analysis.

Changes in Fat and Total Calorie Intake Assessed by Free Buffet Meal Analysis.

Changes in Fasting Glucose

HDL Cholesterol

Triglycerides

Changes in HDL Cholesterol and Triglycerides Assessed by Fasting Lipids

Changes in Inflammation Assessed by C-reactive Protein (CRP)

Changes of Insulin Resistance Assessed by Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

Changes of Circulating Leptin Levels

Of the 41 enrolled participants, 19 out of 23 participants randomized to exenatide once weekly extended-release and 14 out of 18 participants randomized to placebo completed both pre- and post-treatment assessments and are included in this analysis.

Changes of Energy Expenditure Assessed by Doubly Labeled Water Analysis

Of the 41 enrolled participants, 14 out of 23 participants randomized to exenatide once weekly extended-release and 9 out of 18 participants randomized to placebo completed both pre- and post-treatment assessments and are included in this analysis.

Changes of Energy Intake Assessed by Automated Self-Administered 24-Hour Dietary Recall (ASA24-Kids)

Changes in Glucose 120 Minutes Following an Oral Glucose Tolerance Test

Randomization

36-week Randomized Trial

18-week Open Label Extension

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

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

Kathy Miller, MD

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

1. Estimate the effect size of LOFT training on muscle power, endurance, daily activity, fatigue, and quality of life.
2. 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.

Impact of LOFT Therapy™ on Breast Cancer Survivors

Impact of LOFT Therapy™ on Breast Cancer Survivors: A Pilot Study

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Chemotherapy in the Context of Esophageal and Gastroesophageal Junction Cancer Cachexia	NCT05954117	Esophageal Aden...	Adipose tissue ...	18 Years - 99 Years	University Hospital, Clermont-Ferrand
The Physiological Responses and Adaptation of Brown Adipose Tissue to Chronic Treatment With Beta3-Adrenergic Receptor Agonists	NCT03049462	Polycystic Ovar...	Mirabegron B Complex Plus ...	18 Years - 40 Years	National Institutes of Health Clinical Center (CC)
The ICALIC 2 International Multicentric Study	NCT03947294	Cancer Surgery Hemodialysis	Q-NRG®	18 Years -	University Hospital, Geneva
Chemotherapy in the Context of Esophageal and Gastroesophageal Junction Cancer Cachexia	NCT05954117	Esophageal Aden...	Adipose tissue ...	18 Years - 99 Years	University Hospital, Clermont-Ferrand
Energy Balance & Weight Loss in Craniopharyngioma-related or Other Hypothalamic Tumors in Hypothalamic Obesity	NCT02664441	Hypothalamic Ob...	Exenatide placebo	10 Years - 25 Years	Seattle Children's Hospital
Impact of LOFT Therapy™ on Breast Cancer Survivors	NCT02491957	Breast Neoplasm...	LOFT Therapy	18 Years -	Indiana University
Impact of LOFT Therapy™ on Breast Cancer Survivors	NCT02491957	Breast Neoplasm...	LOFT Therapy	18 Years -	Indiana University
Metabolic Effects of Synthetic Thyroid Hormone for Thyroid Cancer Treatment	NCT01441154	Malignant Strum... Papillary Thyro... Hurthle Cell Th... Follicular Thyr... Tall Cell Varia...		18 Years - 99 Years	National Institutes of Health Clinical Center (CC)

Spots Global Cancer Trial Database for energy expenditure