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Nervous System Diseases

Neoplasms

Blood and Lymph Conditions

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Heart and Blood Diseases

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Syndrome

Apnea

Sleep Apnea Syndromes

Sleep Apnea, Obstructive

Polycythemia Vera

Polycythemia

Disease Progression

Thrombocytosis

Thrombocythemia, Essential

Respiration Disorders

Respiratory Tract Diseases

Signs and Symptoms, Respiratory

Parasomnias

Sleep Disorders, Intrinsic

Dyssomnias

Sleep Wake Disorders

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Bone Marrow Neoplasms

Hematologic Neoplasms

Bone Marrow Diseases

Myeloproliferative Disorders

Blood Platelet Disorders

Hemostatic Disorders

Blood Coagulation Disorders

Hemorrhagic Disorders

Essential Thrombocythemia

Chronic Myeloproliferative Disorders

Patients not diagnosed with OSA undergo observation for 6 months.

Patients diagnosed with OSA and prescribed a CPAP machine for treatment receive continuous treatment with CPAP for 6 months.

Continuous Positive Airway Pressure

Patient Observation

Questionnaire Administration

Krishna Sundar

This early phase I trial studies how well the use of a continuous positive airway pressure (CPAP) machine works in treating obstructive sleep apnea in patients with polycythemia vera or essential thrombocythemia. Obstructive sleep apnea is a condition where a person stops breathing during sleep, and is estimated to affect 30 to 50 percent of patients with polycythemia vera or essential thrombocythemia. A patient with obstructive sleep apnea typically snores, has disrupted sleep, experiences morning headaches, and has daytime sleepiness. Patients diagnosed with obstructive sleep apnea are typically treated with a device called CPAP. The CPAP provides pressurized air that keeps upper air passages open during sleep and may prevent them from narrowing or collapsing as occurs during snoring or sleep apnea.

PRIMARY OBJECTIVES:

I. To understand effects of continuous positive airway pressure (CPAP) for obstructive sleep apnea (OSA) on the course of polycythemia vera/essential thrombocythemia (PV/ET).

EXPLORATORY OBJECTIVES:

I. To estimate prevalence of OSA in patients with myeloproliferative neoplasms. II. To understand effects of CPAP for sleep apnea on the course of myeloproliferative neoplasms (MPNs).

III. To correlate OSA severity with thrombotic and inflammatory marker values in patients with PV/ET at baseline.

OUTLINE: Patients are assigned to 1 of 2 cohorts.

COHORT I (OBSERVATIONAL COHORT): Patients not diagnosed with OSA undergo observation for 6 months.

COHORT II (TREATMENT COHORT): Patients diagnosed with OSA and prescribed a CPAP machine for treatment receive continuous treatment with CPAP for 6 months.

CPAP in Treating Obstructive Sleep Apnea in Patients With Polycythemia Vera or Essential Thrombocythemia

Modulation of Morbidity and Disease Progression in Polycythemia Vera (PV) and Essential Thrombocythemia (ET) Patients With Obstructive Sleep Apnea (OSA) by CPAP

Assessed by Snoring, Tiredness, Observed Apnea, Blood Pressure, Body Mass Index, Age, Neck Circumference and Gender (STOP-BANG) questionnaire. The proportion of patients whose results indicate a diagnosis of OSA will be calculated. All patients with a diagnosis of OSA, regardless of whether they are enrolled to the treatment component of the study, will be counted towards the assessment of prevalence. An assessment of normality will be made prior to statistical testing. Paired t tests will be used to analyze endpoints that are sufficiently Gaussian in distribution. Paired Wilcoxon tests will be used to analyze variables that are highly skewed or otherwise non-Gaussian in distribution.

The endpoints will be summarized by mean, median, range, standard deviation, interquartile range and boxplots. Scatterplots will be used to show bivariate associations. An assessment of normality will be made prior to statistical testing. Paired t tests will be used to analyze endpoints that are sufficiently Gaussian in distribution. Paired Wilcoxon tests will be used to analyze variables that are highly skewed or otherwise non-Gaussian in distribution.

Will be measured in blood samples taken from all patients. OSA-related adverse events reported in the Treatment Cohort at these timepoints will be correlated with these marker levels. Pearson or Spearman correlation will be used to assess correlation between thrombo-inflammatory markers and oximetric abnormalities.

Will be tested at the two-sided 0.025 significance level to provide overall control of the type I error for the co-primary endpoints at 0.05. The endpoints will be summarized by mean, median, range, standard deviation, interquartile range and boxplots. Scatterplots will be used to show bivariate associations. An assessment of normality will be made prior to statistical testing. Paired t tests will be used to analyze endpoints that are sufficiently Gaussian in distribution. Paired Wilcoxon tests will be used to analyze variables that are highly skewed or otherwise non-Gaussian in distribution.

National Cancer Institute (NCI)

University of Utah

Respiratory Aspiration

Continuous Positive Airway Pressure (CPAP) will be administered using FDA-approved equipment.

CPAP requires subjects to wear a plastic pressurized mask/apparatus, which is connected via a filter and hose to a pump capable of supplying variable pressure (typically on the range of 4-20 cm H2O). The investigators plan to use a full-face mask to prevent subjects from reducing pressure by opening their mouths. If this cannot be tolerated or properly fitted, or is not compatible with the CPAP ventilator, subjects would use a nasal mask only and be asked to keep their mouths closed.

Erik J Tryggestad, PhD

This study involves a breathing motion assessment in healthy subjects before and after continuous positive airway pressure (CPAP) administration using MRI images.

The hypothesis for this study is that CPAP administration will significantly reduce breathing motion. This may help cancer patients who are undergoing proton radiotherapy, so they possibly will not have to hold their breath during the procedure.

Minimally invasive techniques for tumor motion reduction that involve free-breathing patients have significant relevance in the context of radiation therapy, in particular proton radiotherapy. Tumor motion reduction has favorable implications for reduction of radiation doses to adjacent healthy organs, radiation plan robustness (accuracy/quality) and for treatment efficiency (reduction of treatment times). Using non-ionizing MRI with volunteers, the investigators will determine the extent to which continuous positive airway pressure (CPAP) reduces breathing motion (diaphragmatic excursion). The researchers will also investigate the parameter space associated with breathing motion reduction versus the amount of pressure applied, as well as timing of initiation of CPAP in relation to the imaging time point (to address whether an initial transient breathing state exists).

Impact of Continuous Positive Airway Pressure on Breathing Motion Amplitude

Breathing motion at baseline and at initial (higher but tolerable) CPAP settings will be characterized using fast multi-slice, multi-phase 2D gradient-echo or spin-echo MRI sequences in the sagittal or coronal imaging planes over a large field of view covering the thoracic and upper-abdominal region. Specifically "4D-MRI" (or time-resolved MRI) will be generated from retrospective sorting of multi-slice 2D MRI. For these analyses, anatomic reference points (e.g., bright vessels) in multiple organ systems will be identified on the images, contoured or segmented; subsequently 3D motion patterns will be extracted for all anatomical references/features. Numerical simulations will be performed to determine hypothetical radiation target volume changes (cm\^3) at these anatomic locations assuming spherical tumors with a given set of tumor diameters (cm).

Time permitting, the CPAP setting will be reduced to approximately half of the nominal/tolerable/high CPAP setting. Using the same MRI sequences and retrospective sorting technique, 4D-MRI will be generated for this lower CPAP setting. Analogous motion characterization analyses (to outcome measure 1) will be carried out for the lower CPAP setting (relative to baseline 4D-MRI).

Mayo Clinic

Associate Professor of Medical Physics

Skin and Connective Tissue Diseases

Lung Neoplasms

Breast Neoplasms

Unilateral Breast Neoplasms

Breast Diseases

Skin Diseases

Participants will come in for their regularly scheduled radiation planning and treatment. Participants will undergo three scans (with and without DIBH (i.e., free-breathing), with CPAP). Participants will also use the CPAP device before the CT scan, for which they will be educated and trained.

Use of CPAP device at the start of treatment planning.

Treatment during breath holds leads to longer treatment times for patients and radiation oncology departments

Deep inspiratory breath hold

Free Breath

Chirag Shah, MD

Chirag Shah, M.D.

Data collection and assessment on patients with left-sided breast cancer or undergoing lung stereotactic body radiation therapy (SBRT) utilizing continuous positive airway pressure (CPAP) devices.

Lung stereotactic body radiation therapy (SBRT) has emerged as a definitive treatment for patients with early-stage lung cancers as well as for patients with limited metastases to the lung. One challenge with the treatment of the lung is the risk of pulmonary toxicity, particularly for early-stage lungs cancers that are inoperable (those receiving primary lung SBRT) or those with metastatic cancers receiving systemic therapy that may impact pulmonary function (those receiving lung SBRT for metastatic cancers).

Continuous positive airway pressure (CPAP) devices are commonly utilized for patients with obstructive sleep apnea. However, through the use of continuous pressure, lung volumes are increased. Preliminary data in patients undergoing breast radiation as well as lung radiation has demonstrated the safety and feasibility of such an approach, demonstrating increased lung volumes with decreases in heart dose6-8. Additional potential advantages of CPAP include increased ease of use for patients and the potential for cost savings as compared to traditional respiratory management techniques.

This prospective study is to allow for the collection and assessment of data on patients with left-sided breast cancer or undergoing lung SBRT utilizing CPAP. This will allow for the assessment of lung doses with and without CPAP as well as cardiac doses. No additional changes to our standard of care breast or lung radiation will occur. With respect to the safety profile, CPAP is commonly used with limited toxicity concerns. The potential benefit of CPAP has reduced lung and heart doses and, consequently, radiation-related toxicities.

All participants will undergo standard of care radiation treatment. One additional CT scan will be performed with the use of a CPAP device to determine effect on dosimetry.

A Prospective Study to Evaluate Continuous Positive Airway Pressure Devices to Reduce Pulmonary Dose

The primary objective will be to assess changes in lung dosimetry V5 on the affected side when using CPAP compared to free breathing will be measured in percentages.

The primary objective will be to assess changes in lung dosimetry V20 on the affected side when using CPAP compared to free-breathing will be measured in percentages.

The primary objective will be to assess changes in lung dosimetry mean lung on the affected side when using CPAP compared to free-breathing will be measured in Grays.

Total Lung dosimetry will be measured in Grays.

Cardiac dosimetry with CPAP as compared to free-breathing will be measured in Grays.

Simulation scans will be performed with CPAP and free breathing. The breast/chest wall, and tumors (lung SBRT), as well as lung and heart, will be contoured on each scan. Using the CPAP scan as a reference, we will assess breast/chest wall motion, lung tumor motion, and organ at risk (ex. heart, abdominal organs) motion with free-breathing scans for each patient and analyze by treatment site (breast vs. lung SBRT).

Treatment time will be measured for each fraction

At the time of simulation, investigators will create a surface rendering with the patient using CPAP. Investigators will assess maintenance of inflation when using CPAP where all three dimensions will be measured during treatment by comparing the surface rendering obtained during simulation with CPAP to the surface during treatment with CPAP, assessing for the greatest changes over the course of each fraction.

Varian Medical Systems

Case Comprehensive Cancer Center

Nutritional and Metabolic Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

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

All Drugs and Chemicals

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

Reproductive Control Agents

Estradiol

Dexamethasone

Methyltestosterone

Estrogens

Glucocorticoids

Dexamethasone acetate

Estradiol 17 beta-cypionate

Estradiol 3-benzoate

Polyestradiol phosphate

Testosterone

Testosterone undecanoate

Testosterone enanthate

Testosterone 17 beta-cypionate

Progesterone

Hormones

Hormone Antagonists

Androgens

Progestins

Women with obesity and polycystic ovary syndrome

Women and men with obesity and obstructive sleep apnea

Lean and obese healthy women, and obese men

Postmenopausal women - tested before and after no treatment. Duration between before and after testing ranged from 31 to 78 days with an average of 46 days between visits

Micronized progesterone, 100 mg/d vaginally. The intervention lasts 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment. Testing is performed before and at the end of the 70 day intervention.

Testosterone gel 1250 ug/d applied transdermally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention.

testosterone

Dexamethasone 0.013 mg/kg fat-free mass daily taken orally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention.

glucocorticoid

Breathe through the mask of a continuous positive airway pressure device every night when sleep, for 6 weeks. Testing is performed before and at the end of the 6 week intervention.

continuous positive airway pressure

Estrogen treatment (100 ug Estradiol daily) administered transdermally by using continuous delivery patches. The intervention lasted 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment.

Estrogen

No treatment with studies performed 31 to 72 days apart

Control

Bettina Mittendorfer, PhD

Increased plasma triglyceride concentration is a common feature of the metabolic abnormalities associated with obesity and a major risk factor for cardiovascular disease. Obesity is a major risk factor for two conditions that appear to be increasing in prevalence in women: the polycystic ovary syndrome (PCOS) and sleep disordered breathing. PCOS affects 5-8% of women. Sleep disordered breathing affects up to 10% of women. Obstructive sleep apnea (OSA) is the most common cause for sleep disordered breathing and particularly prevalent in obese women with PCOS (\~50%). Both PCOS and OSA augment the increase in plasma triglyceride (TG) concentration associated with obesity, and the effects of PCOS and OSA on plasma TG concentration appear to be additive. The mechanisms responsible for the adverse effects on plasma TG metabolism are not known. The primary goal of this project, therefore, is to determine the mechanisms responsible for the increase in plasma TG concentration in obese women with PCOS and OSA. It is our general hypothesis that alterations in the hormonal milieu that are characteristic of these two conditions are, at least in part, responsible for the increase in plasma TG concentration in obese women with the conditions. Furthermore, we hypothesize that the hormonal aberrations characteristic of the two conditions are particularly harmful to obese, compared with lean, women.

The effects of PCOS on skeletal muscle protein metabolism are also not known. However, sex hormones are thought to be important regulators of muscle protein turnover suggesting that muscle protein metabolism is likely to be affected by PCOS. We will examine this by determining the effect of individual sex hormones on muscle protein metabolism and hypothesize that testosterone administration will stimulate muscle protein metabolism while estrogen and progesterone administration will inhibit muscle protein metabolism.

Sex Steroids, Sleep, and Metabolic Dysfunction in Women

VLDL was isolated from plasma by ultracentrifugation with the tracer-to-tracee (TTR) of free glycerol in plasma and glycerol in VLDL-TG determined by gas chromatography-mass spectrometry. The fractional turnover rates of VLDL-TG was determined by fitting the glycerol TTR time courses in plasma and in VLDL-TG to a multicompartmental model. The hepatic (liver) secretion rates of VLDL-TG was calculated by multiplying the fractional turnover rates of VLDL-TG by the of VLDL-TG concentration.

VLDL was isolated from plasma by ultracentrifugation with VLDL-TG concentration measured by using a colorimetric enzymatic kit (Sigma-Aldrich, St. Louis, MO).

VLDL was isolated from plasma by ultracentrifugation with the tracer-to-tracee (TTR) of free glycerol in plasma and glycerol in VLDL-TG determined by gas chromatography-mass spectrometry. The fractional turnover rates of VLDL-TG was determined by fitting the glycerol TTR time courses in plasma and in VLDL-TG to a multicompartmental model. The plasma clearance rate of VLDL-TG was calculated by dividing the VLDL-TG secretion rate by the VLDL-TG concentration.

The fractional synthesis rate (FSR) of muscle protein synthesis was determined by assessing the incorporation of \[5,5,5-2H3\]leucine into muscle proteins. \[5,5,5-2H3\]leucine was infused for 5 hours with muscle biopsies obtained from the vastus lateralis muscle in the thigh 2 and 5 hours. The leucine tracer-to-tracee ratio (TTR) in muscle protein and the muscle free leucine pool was determined by gas chromatography-mass spectrometry (GCMS) and the FSR of muscle proteins calculated using a standard precursor-product model.

The FSR was calculated as %/h, which reflects the percent of all proteins in the muscle that were synthesized (made) per hour.

Washington University School of Medicine

Healthy, premenopausal women.

Testosterone gel 1250 ug/d applied transdermally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention.

Testosterone - Premenopausal Women

Postmenopausal women

Testosterone gel 1250 ug/d applied transdermally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention.

Testosterone - Postmenopausal Women

Women with obesity and polycystic ovary syndrome

Micronized progesterone, 100 mg/d vaginally. The intervention lasts 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment. Testing is performed before and at the end of the 70 day intervention.

Progesterone - PCOS

Postmenopausal women

Micronized progesterone, 100 mg/d vaginally. The intervention lasts 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment. Testing is performed before and at the end of the 70 day intervention.

Progesterone - Postmenopausal Women

Obese women and men with obstructive sleep apnea

Breathe through the mask of a continuous positive airway pressure device every night when sleep, for 6 weeks. Testing is performed before and at the end of the 6 week intervention.

Lean and obese healthy women, and obese men

Dexamethasone 0.013 mg/kg fat-free mass daily taken orally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention.

Glucocorticoid

Postmenopausal women

Estrogen treatment (100 ug Estradiol daily) administered transdermally by using continuous delivery patches. The intervention lasted 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment.

Postmenopausal women

Tested before and after no treatment. Duration between before and after testing ranged from 31 to 78 days with an average of 46 days between visits

Healthy men and women

Baseline testing only

Control - Baseline Testing Only

Healthy, premenopausal women

Testosterone gel 1250 ug/d applied transdermally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention

Women and men with obesity and obstructive sleep apnea

continuous positive airway pressure: Breathe through the mask of a continuous positive airway pressure device every night when sleep, for 6 weeks

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Gordon Smith, PhD

Before

After

Women and men with obesity and obstructive sleep apnea

Continuous positive airway pressure: Breathe through the mask of a continuous positive airway pressure device every night when sleep, for 6 weeks

Not included in final analysis:

Withdrawn/withdrew= Testosterone premenopausal women x 1; Progesterone postmenopausal women x 2; Glucocorticoid x 3.

VLDL-TG fractional turnover rate was 3 Standard Deviations from the mean = Testosterone - premenopausal women x 1.

Undetectable VLDL-TG concentration = Progesterone - Postmenopausal women x 1.

Very-Low Density Lipoprotein-Triglyceride (VLDL-TG) Secretion Rate

Not included in final analysis:

Withdrawn/withdrew = Testosterone premenopausal women x 1; Progesterone postmenopausal women x 2; Glucocorticoid x 3.

VLDL-TG fractional turnover rate was 3 Standard Deviations from the mean = Testosterone - premenopausal women x 1.

Undetectable VLDL-TG concentration = Progesterone - Postmenopausal women x 1.

Very-Low Density Lipoprotein-Triglyceride (VLDL-TG) Concentration

Healthy premenopausal women.

Testosterone gel 1250 ug/d applied transdermally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention.

Obese women and men with obstructive sleep apnea

continuous positive airway pressure: Breathe through the mask of a continuous positive airway pressure device every night when sleep, for 6 weeks

Postmenopausal women

Postmenopausal women - tested before and after no treatment. Duration between before and after testing ranged from 31 to 78 days with an average of 46 days between visits

VLDL-TG Plasma Clearance Rate (Means)

VLDL-TG Plasma Clearance Rate (Medians)

Not included in final analysis:

Withdrawn/withdrew = Testosterone premenopausal women x 1; Progesterone postmenopausal women x 2; Glucocorticoid x 3.

Muscle not obtained = Testosterone - premenopausal women x 1; Progesterone postmenopausal women x 1; CPAP x 3; Glucocorticoid x 6; Control - baseline testing only x 6.

Basal, Postabsorptive Fractional Synthesis Rates of Muscle Protein Synthesis

Women with obesity and polycystic ovary syndrome

Progesterone: Micronized progesterone, 100 mg/d vaginally. The intervention lasts 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment. Testing is performed before and at the end of the 70 day intervention.

Postmenopausal women

Progesterone: Micronized progesterone, 100 mg/d vaginally. The intervention lasts 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment. Testing is performed before and at the end of the 70 day intervention.

Healthy premenopausal women

Testosterone: Testosterone gel 1250 ug/d applied transdermally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention.

Postmenopausal women

Testosterone: Testosterone gel 1250 ug/d applied transdermally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention.

Lean and obese healthy women, and obese men

glucocorticoid: Dexamethasone 0.013 mg/kg fat-free mass daily, 21 days

Postmenopausal women

Estrogens: Estrogen treatment (100 ug Estradiol daily) administered 14 days followed by 14 days without treatment. Repeat this cycle 3 times.

Baseline testing only in pre- and postmenopausal women

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
CPAP in Treating Obstructive Sleep Apnea in Patients With Polycythemia Vera or Essential Thrombocythemia	NCT03972943	CALR Gene Mutat... Essential Throm... JAK2 Gene Mutat... MPL Gene Mutati... Obstructive Sle... Polycythemia Ve...	Continuous Posi... Patient Observa... Questionnaire A...	30 Years - 85 Years	University of Utah
Impact of Continuous Positive Airway Pressure on Breathing Motion Amplitude	NCT02852473	Cancer	Continuous Posi...	18 Years -	Mayo Clinic
A Prospective Study to Evaluate Continuous Positive Airway Pressure Devices to Reduce Pulmonary Dose	NCT05142358	Lung Cancer Left Sided Brea...	Continuous Posi... Deep inspirator... Free Breath	18 Years -	Case Comprehensive Cancer Center
CPAP in Treating Obstructive Sleep Apnea in Patients With Polycythemia Vera or Essential Thrombocythemia	NCT03972943	CALR Gene Mutat... Essential Throm... JAK2 Gene Mutat... MPL Gene Mutati... Obstructive Sle... Polycythemia Ve...	Continuous Posi... Patient Observa... Questionnaire A...	30 Years - 85 Years	University of Utah
A Prospective Study to Evaluate Continuous Positive Airway Pressure Devices to Reduce Pulmonary Dose	NCT05142358	Lung Cancer Left Sided Brea...	Continuous Posi... Deep inspirator... Free Breath	18 Years -	Case Comprehensive Cancer Center
CPAP in Treating Obstructive Sleep Apnea in Patients With Polycythemia Vera or Essential Thrombocythemia	NCT03972943	CALR Gene Mutat... Essential Throm... JAK2 Gene Mutat... MPL Gene Mutati... Obstructive Sle... Polycythemia Ve...	Continuous Posi... Patient Observa... Questionnaire A...	30 Years - 85 Years	University of Utah
Sex Steroids, Sleep, and Metabolic Dysfunction in Women	NCT00805207	Polycystic Ovar... Obstructive Sle... Obesity	Progesterone testosterone glucocorticoid continuous posi... Estrogen Control	18 Years - 75 Years	Washington University School of Medicine

Spots Global Cancer Trial Database for continuous positive airway pressure