Symptoms and General Pathology

All Conditions

Nutritional and Metabolic Diseases

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Heart and Blood Diseases

Syndrome

Obesity

Polycystic Ovary Syndrome

Prehypertension

Prediabetic State

Metabolic Syndrome

Glucose Intolerance

Insulin Resistance

Hyperinsulinism

Metabolic Diseases

Glucose Metabolism Disorders

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

Vascular Diseases

Subjects assigned to heat therapy underwent 30 1-hour hot tub sessions over 8-10 weeks (3-4 per week). The hot tub was set to 40.5 Celsius, and core temperature and heart rate were monitored throughout each session.Subjects were instructed to not make any other dietary or lifestyle changes.Cardiovascular and metabolic health assessments were made Pre (0 heat sessions), mid (after 14-16 heat sessions, \~4-5 weeks), and post (after all 30 heat sessions; \~8-10 weeks).

Subjects were monitored at matched timepoints (start of study, 4-5 weeks, and 8-10 weeks) but not exposed to any intervention. Subjects were instructed to not make any dietary or lifestyle changes.

Heat therapy

Traditional medical treatments are often based on research done exclusively in males, and recent research efforts in the physiology community have highlighted critical sex differences in disease presentation and progression. For example, the relative risk of fatal heart disease is 50% greater in obese, diabetic women as compared to their male counterparts, and women appear to respond differently to lifestyle interventions such as exercise compared with men. Chronic passive heat exposure (hot tub use) provides alternative or supplemental therapeutic potential for improving cardiovascular and metabolic health in obese women. In addition, passive heat exposure may offer specific cellular protection from stresses like a lack of blood flow (ischemia), which is the primary cause of fatal coronary heart disease. This study is investigating the possible cardiovascular and metabolic health benefits of chronic passive heat exposure, and whether regular hot tub use (3-4 days per week for 8-10 weeks) may reduce obese womens' cardiometabolic risk. The investigators are examining cardiovascular health through blood pressure, blood vessel stiffness, sympathetic ('fight or flight') activity, and responsiveness to stresses like increased or decreased blood flow. The investigators are also examining metabolic health through an oral glucose tolerance test and a subcutaneous fat biopsy. The goal of this research is to develop a therapy targeted toward the specific health needs and complications of obese women, in an effort to improve cardiovascular and metabolic health and provide therapeutic alternatives in this high-risk population.

Subjects were matched for age and BMI, then assigned to either a heat therapy intervention or time control (no intervention, just outcomes assessment at matched timepoints).

It was not possible to blind the subject or PI to treatment group, but all measures that were collected were analyzed offline by a blinded investigator.

Heat Therapy and Cardiometabolic Health in Obese Women

serum measurement of high-sensitivity C-reactive protein, global inflammatory marker

Resting supine blood pressure, measured in triplicate with median recorded

glucose and insulin responses to a 75-g, 2-hr oral glucose tolerance test after a 12+hr fast

recording of sympathetic nerve traffic during supine rest, quantified as burst count per minute

intimal thickness of common carotid artery assessed using doppler ultrasonography

intimal thickness of superficial femoral artery assessed using doppler ultrasonography

arterial compliance of common carotid artery measured using ultrasonography

arterial compliance of superficial femoral artery measured using ultrasonography

flow-mediated dilation of brachial artery, expressed as % change in diameter. A measure of endothelial function.

flow-mediated dilation of brachial artery, expressed as % change in diameter, following 20 minute ischemia-20 minute reperfusion. A measure of vascular tolerance to ischemia-reperfusion stress.

Adipose tissue sample analyzed for insulin signaling, markers of inflammation, and heat shock protein expression

American Heart Association

University of Oregon

Kenneth & Kenda Singer Endowed Professor

Skin and Connective Tissue Diseases

Substance Related Disorders

Wounds and Injuries

Rare Diseases

Breast Neoplasms

Cardiotoxicity

Heart Diseases

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Radiation Injuries

Chronic Graft Versus Host Disease

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Vasodilator Agents

Respiratory System Agents

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Superoxide Dismutase

Nitric Oxide

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

The patients will be assessed before and after chemotherapy treatment.

Body weight, height and waist circumference

Physical Characteristics

Muscular Sympathetic Nervous Activity

Cardiac Function

Heart rate

Blood pressure

Serum and Plasma will be extracted by centrifugation. Endothelial microparticles by flow cytometry Interleukin-6 and tumor necrosis factor α by ELISA, High-sensitive reactive serum C-reactive protein by immunoturbidimetric assay, NT- ProBNP According to Central Laboratory, Hospital das Clinicas, HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo. Endothelin-1 by immunoenzymatic method Nitric oxide by gas chemiluminescence Lipoperoxidation by fluorimetry Carbonyl by spectrophotometer, and Superoxide Dismutase (SOD) by colorimetry.

Blood Assessments

Muscle blood flow

Endothelium-dependent vascular function

Vascular intima-media thickness

Physical Capacity

Four session of intravenous (in bolus) infusion of doxorubicin 60mg/m2 and cyclophosphamide 600mg/m2 with an interval of 21 days between sessions.

Anthracycline & Cyclophosphamide treatment scheme

Raphaela VR Groehs, PhD

Ursula Urias, PhD

Carlos Eduardo Negrao, PHD

Carlos E Negrao, PhD

The present study aims to investigate the chronic effect of treatment with doxorubicin and cyclophosphamide on neurovascular control and blood pressure in women undergoing adjuvant treatment for breast cancer.

The development of new drugs and different adjuvant therapeutic regimens, based on the combination of anthracycline (A) and cyclophosphamide (C), have contributed greatly to improve survival rate in breast cancer patients. Despite the clinical benefits of this therapy, AC treatment can cause cardiovascular acute and chronic changes. In a recent investigation, we observed that an acute AC chemotherapy session increases sympathetic nervous activity and blood pressure in patients with breast cancer.

The present study aims to investigate the chronic effects of AC regimen on sympathetic nervous activity, peripheral vasoconstriction, endothelial microparticles and blood pressure, in women with breast cancer.

Effect of Anthracyclines and Cyclophosphamide on Cardiovascular Responses

Chronic Effect of Doxorubicin and Cyclophosphamide on Neurovascular Control and Blood Pressure in Women in Adjuvant Treatment for Breast Neoplasia

Change in muscular sympathetic nerve activity measured by microneurography

Change in muscle blood flow measured by venous oclusion plethysmography

Change in blood pressure measured by finometer

Change in physical capacity measured by cardiopulmonary exercise test

Change in cardiac function measured by echocardiography

Universidade Federal Fluminense

Hospital Israelita Albert Einstein

University of Sao Paulo General Hospital

Behaviors and Mental Disorders

Quality of Life

Hypoglycemic Agents

Androgens

Insulin

Insulin, Globin Zinc

Electroacupuncture

Physical exercise

Untreated control

Elisabet Stener-Victorin, Prof, PhD

Hypothesis:

The overall hypothesis is that women with PCOS, both obese and non-obese, have larger adipocytes, altered metabolism and signs of inflammation in adipose tissue and that these changes are associated with high sympathetic nerve activity, hyperandrogenism hyperinsulinaemia, insulin resistance with progression to type II diabetes and cardiovascular disease (CVD) as well as psychological distress and reduced quality of life. Physical exercise and electro-acupuncture decrease high concentrations of androgens, induce regulare menstrual pattern, inhibits high sympathetic activity and restore the PCOS induced disturbances.

Primary outcome: Changes in androgen concentrations and menstrual pattern

Secondary outcome: changes in sympathetic nerve activity, uterus peristalsis, ovarian morphology, adipose tissue related variables, insulin sensitivity, coagulation factors and health related quality of life and symptoms of anxiety and depression.

Polycystic Ovary Syndrome (PCOS) - Effect Of Physical Exercise And Electroacupuncture

Polycystic Ovary Syndrome (PCOS) - The Female Metabolic Syndrome Genes And Processes In The Aetiology And Pathogenesis Of PCOS And Identification Of New Treatment Strategies

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Heat Therapy and Cardiometabolic Health in Obese Women	NCT03644524	Obesity Polycystic Ovar... Prehypertension PreDiabetes Cardiovascular ... Metabolic Syndr...	Heat therapy	18 Years - 40 Years	University of Oregon
Effect of Anthracyclines and Cyclophosphamide on Cardiovascular Responses	NCT04568161	Cardiotoxicity Cardiovascular ... Neurovascular D... Endothelial Dis... Breast Cancer	Physical Charac... Muscular Sympat... Cardiac Functio... Heart rate Blood pressure Blood Assessmen... Muscle blood fl... Endothelium-dep... Vascular intima... Physical Capaci... Anthracycline &...	45 Years - 60 Years	University of Sao Paulo General Hospital
Heat Therapy and Cardiometabolic Health in Obese Women	NCT03644524	Obesity Polycystic Ovar... Prehypertension PreDiabetes Cardiovascular ... Metabolic Syndr...	Heat therapy	18 Years - 40 Years	University of Oregon
Effect of Anthracyclines and Cyclophosphamide on Cardiovascular Responses	NCT04568161	Cardiotoxicity Cardiovascular ... Neurovascular D... Endothelial Dis... Breast Cancer	Physical Charac... Muscular Sympat... Cardiac Functio... Heart rate Blood pressure Blood Assessmen... Muscle blood fl... Endothelium-dep... Vascular intima... Physical Capaci... Anthracycline &...	45 Years - 60 Years	University of Sao Paulo General Hospital
Polycystic Ovary Syndrome (PCOS) - Effect Of Physical Exercise And Electroacupuncture	NCT00484705	Polycystic Ovar...	Electroacupunct... Physical exerci... Untreated contr...	18 Years - 37 Years	Göteborg University

Spots Global Cancer Trial Database for muscle sympathetic nerve activity