Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Heart and Blood Diseases

Symptoms and General Pathology

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

Nervous System Diseases

Anxiety Disorders

Chronobiology Disorders

Breast Diseases

Skin Diseases

Central Nervous System Depressants

Other Dietary Supplements

Melatonin

12 breast cancer patients aged 30-70 years undergoing a lumpectomy at Herlev Hospital. ASA score I-III.

Wrist-Actigraph to be worn on the non-dominant arm on day 0-3-17 of the study.

Wrist-Actigraph - Octagonal Basic Motionlogger, Ambulatory monitoring Inc, New York, USA

Polysomnography on day 0-3-17 of the study. This is a portable polysomnograph with 16 digital channels for recording of electroencephalogram (EEG), electrooculograph (EOG) and electromyograph (EMG).

Polysomnograph - Embla A10 (Medcare, Reykjavik, Iceland)

Holter monitoring on day 0-3-17 of the study. Measurements are done by superficial skin-electrodes placed after standardised rules from the producer of the device.

Holter monitor - Medilog AR12 (Oxford Instruments, Oxford, England)

Urine sampling for measurement of the primary metabolite of melatonin - 6-sulphatoxymelatonin (aMT6s) will be done on day 0-3-17 of the study. The analysis will be done by a radioimmunoassay.

Urine 6-sulphatoxymelatonin (aMT6s)

Karolinska Sleepiness Scale to measure sleepiness will be filled out twice a day every day of the entire study period of 17 days.

Karolinska Sleepiness Scale

Visual Analog Scale and 10 point-scales to measure fatigue, general well-being, subjective sleep and pain will be filled out twice a day everyday of the study period of 17 days.

Visual Analog Scale and 10 point-scales to measure fatigue, general well-being, subjective sleep and pain

Sleep-diary to measure subjective sleep quantity will be completed every morning and after every nap in the day.

Sleep-diary

Melissa V Hansen, MD

The purpose of this study is to investigate circadian disturbances after breast cancer surgery by means of monitoring sleep and heart-rate variability, by measuring a metabolite of melatonin in urine and by questionnaires and a sleep-diary.

An increasing number of studies have shown that circadian variation in the excretion of hormones, the sleep-wake cycle, the core body temperature, the tone of the autonomic nervous system and the activity rhythm are important both in health and disease processes. More attention is being paid towards the circadian variation in endogenous rhythms in relation to surgery and whether this can affect postoperative recovery, morbidity and mortality.

Studies have been done on circadian disturbances after major and minor surgery but never in relation to breast cancer surgery.

This study will investigate circadian disturbances in this specific group of patients by using Actigraphy, Polysomnography (PSG), Holter-monitoring (HRV), the primary metabolite of melatonin in urine 6-sulfatoxymelatonin (aMT6s), questionnaires and a sleep-diary.

Circadian Disturbances After Breast Cancer Surgery

Sleep architecture measured by Polysomnography (awake, stadium I-IV, REM sleep, sleep latency, awakenings).

Sleep architecture measured by Polysomnography (awake, stadium I-IV, REM sleep, sleep latency, awakenings)

Fatigue, generel well-being, subjective sleep and pain scores on a Visual Analog Scale - questionnaires filled out daily. Sleepiness measured by Karolinska Sleepiness Scale. A sleep-diary recording sleep quantity of day and night sleep.

Excretion of aMT6s in urine. Urine will be collected from 23-07, quantified and 2 samples will be taken to measure aMT6s.

Actigraphy (total minutes asleep, sleep effectiveness, sleep latency, awakenings). A wrist actigraph wil be worn from 1 day preoperatively and taken off on the 14th postoperative day.

Heart-rate variability measured by Holter monitor and a following analysis of frequency domain parameters.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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
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
Circadian Disturbances After Breast Cancer Surgery	NCT01171508	Circadian Rhyth... Anxiety Breast Cancer	Wrist-Actigraph... Polysomnograph ... Holter monitor ... Urine 6-sulphat... Karolinska Slee... Visual Analog S... Sleep-diary	30 Years - 70 Years	Herlev Hospital

Spots Global Cancer Trial Database for heart rate

Every month we try and update this database with for heart rate 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.

Spots Global Cancer Trial Database for heart rate

Every month we try and update this database with for heart rate 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.

Every month we try and update this database with for heart rate 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.