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

Digestive System Diseases

Immune System Diseases

Carcinoma

Neoplasm Metastasis

Carcinoma, Hepatocellular

Liver Neoplasms

Hypersensitivity

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Neoplastic Processes

Antineoplastic Agents

All Drugs and Chemicals

Hematinics

Doxorubicin

Liposomal doxorubicin

Liver Extracts

ThermoDox administered as single dose intravenously over 30 minutes in combination with radiofrequency ablation. Dose is determined by dose cohort patient enters study.

15 ml vial containing 2mg/ml Doxorubicin HCl, DPPC, MSPC, DSPE-MPEG 2000. Administered as single dose intravenously over 30 minutes. Dose is determined by dose cohort patient enters study.

ThermoDox

The purpose of this study is to determine the maximum tolerated dose (MTD) of ThermoDox when used in combination with radiofrequency ablation (RFA) in the treatment of primary and metastatic tumors of the liver.

Ablative treatment approaches, such as RFA or microwave ablation, have received increased attention as alternates to other treatment approaches such as hepatic arterial embolization or chemoembolization (TACE) or percutaneous ethanol injection (PEI) in the majority of patients who are either not candidates for surgical resection or are not offered palliative supportive care only for diffuse disease. RFA can be applied repetitively to the same patient to treat multiple tumors at time of diagnosis or upon tumor recurrence (local or distant to the site of ablation), and is largely limited in its application only by tumor location and size (tumors near larger vessels, bowel or the hepatobiliary tree are more difficult to ablate). To extend the volume of the ablation region in a controlled fashion in patients and to improve the ability to kill tumor cells in the ablation margin region and allow for the improved treatment of HCC and MLC lesions \> 3 cm in diameter by complete thermal ablation, Celsion Corporation has developed ThermoDox, a thermally sensitive, intravenously administered liposomal formulation of doxorubicin capable of selectively releasing its drug contents when exposed to temperatures of \> 39.5°C. The concept behind this treatment approach is to create a large concentration gradient of doxorubicin in the immediate region of the tumor which borders the zone of RFA induced cell necrosis. The temperature isotherms produced in this boundary region should be adequate to activate doxorubicin release by the thermally sensitive liposomes deposited locally around the ablation zone. This in effect increases the region of tissue that can be treated beyond that achievable by RFA alone. Several clinical objectives are being tested in this study. The MTD for ThermoDox is to be confirmed. This study will assess the safety of using ThermoDox in conjunction with RFA over multiple cycles, consistent with the clinical needs of the subjects. While this study is not powered to define effectiveness of the combination of RFA plus ThermoDox, the results of this study should allow for an assessment of risk and benefit for designing future studies. This study will also test alternative infusion reaction prophylaxis regimens.

A Study of ThermoDox™ in Combination With Radiofrequency Ablation (RFA) in Primary and Metastatic Tumors of the Liver

A Phase I Dose Escalation Tolerability Study of ThermoDox™ (Thermally Sensitive Liposomal Doxorubicin) in Combination With Radiofrequency Ablation (RFA) of Primary and Metastatic Tumors of the Liver

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
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
A Study of ThermoDox™ in Combination With Radiofrequency Ablation (RFA) in Primary and Metastatic Tumors of the Liver	NCT00441376	Hepatocellular ... Liver Neoplasms	ThermoDox	18 Years -	Imunon

Spots Global Cancer Trial Database for heat therapy

Every month we try and update this database with for heat therapy cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.