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

Breast Diseases

Skin Diseases

Chronic Graft Versus Host Disease

Antineoplastic Agents

All Drugs and Chemicals

Doxorubicin

Liposomal doxorubicin

Antioxidants

Mitoquinone

Placebo

Allan Kluser Sales, PhD

Investigate the protective effect of chronic MitoQ supplementation on cardiovascular toxicity induced by doxorubicin-based adjuvant chemotherapy in breast cancer patients.

Test the hypothesis that chronic MitoQ supplementation in breast cancer patients treated with doxorubicin prevents:

1. increased mitochondrial oxidative stress;
2. the increase in cardiac markers (B-type natriuretic peptide and troponin I);
3. changes in left ventricular deformity (speckle tracking, strain) and reduction in LVEF;
4. endothelium-dependent dysfunction of peripheral vascular beds;
5. the increase in endothelial microvesicles;
6. the increase in material stiffness;
7. the elevation of central blood pressure.

Clinical, randomized, double-blind, placebo-controlled trial.

The Impact of Chronic Mitochondrial Antioxidant Supplementation on CardiovascularToxicity in Breast Cancer Patients

The Impact of Chronic Mitochondrial Antioxidant (MitoQ) Supplementation on Cardiovascular Toxicity Induced by Doxorubicin-Based Adjuvant Chemotherapy in Breast Cancer Patients: Randomized Clinical Trial

Cardiac function changes (Strain and Simpson's monoplanar)

Mitochondrial oxidative stress; Cardiac markers (B-type natriuretic peptide and troponin I);

changes in the endothelium-dependent function of peripheral vascular beds

Alterations on the central blood pressure

InCor Heart Institute

Instituto do Cancer do Estado de São Paulo

D'Or Institute for Research and Education

Digestive System Diseases

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Herbal and Botanical

Fluorouracil

Oxaliplatin

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Cola

adjuvant chemotherapy with 5-FU associated with oxaliplatin

Patients submitted to adjuvant chemotherapy with 5-FU isolated

adjuvant chemotherapy with 5-FU isolated

Patients submitted to adjuvant chemotherapy with 5-FU associated with oxaliplatin

The present study aims to investigate the impact of adjuvant chemotherapy with 5-FU isolated and associated with oxaliplatin in cardiac autonomic control and endothelium-dependent vascular function in patients undergoing colectomy for stages II and III colon cancer. Will be performed evaluation of cardiac and vascular function, autonomic control, functional capacity and blood evaluations.

Cancer is a major public health problem. Colorectal cancer is the third most common cancer in men and women around the world. Despite advances in surgical and pharmacological treatment, this type of cancer remains a leading cause of cancer death in Western countries. The adjuvant chemotherapy treatment based on the use of fluoropyrimidine, especially 5-fluorouracil (5-FU) is the mainstay of the pharmacological treatment of colorectal cancer. This treatment showed benefit in overall survival and progression-free survival in the adjuvant treatment of patients with stage II and III disease. In the last decade, the combination treatment with oxaliplatin has shown benefit in patients with either metastatic disease as with locoregional disease who underwent surgical treatment. However, the increased use of 5-FU and oxaliplatin, and increased patient survival have caused increased incidence of adverse events. 5-FU has cardiotoxic effects that may range from 1.2 to 18% depending upon the drug administration. Another adverse event of chemotherapy for colon cancer is neurotoxicity. Peripheral neuropathy is one of the toxicities associated with treatment with Oxaliplatin and its characteristics to be dose-dependent and cumulative. Thus, the adjuvant chemotherapy with 5-FU and oxaliplatin may cause cardiotoxicity, changes in vascular function and increased oxidative stress. What is not known are the effects of treatment of 5-FU and oxaliplatin in cardiac autonomic modulation and peripheral vascular function. Therefore, the present study aims to investigate the impact of adjuvant chemotherapy with 5-FU isolated and associated with oxaliplatin in cardiac autonomic control and endothelium-dependent vascular function in patients undergoing colectomy for stages II and III colon cancer. Will be performed evaluation of cardiac and vascular function, autonomic control, functional capacity and blood evaluations.

Patients with stage II disease undergoing adjuvant 5-FU treatment will be allocat in chemotherapy-1 group, while stage III patients undergoing combined adjuvant chemotherapy (5FU + Oxaliplatin) will be allocat to the Chemotherapy group -2.

Impact of Adjuvant Chemotherapy in Patients With Colon Cancer

Impact of Adjuvant Chemotherapy in Cardiovascular Autonomic Regulation in Patients With Colon Cancer

Cardiac function will be assessed by two-dimensional (B-mode) echocardiography, pulsed Doppler

Vascular function will be assessed by high resolution Doppler ultrasound

autonomic control will be assessed by microneurography and heart rate variability

functional capacity will be assessed by cardiopulmonary exercise test

Proinflammatory cytokines will be assessed by blood evaluations

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Impact of Chronic Mitochondrial Antioxidant Supplementation on CardiovascularToxicity in Breast Cancer Patients	NCT05146843	Breast Neoplasm...	Mitoquinone Placebo	18 Years - 75 Years	D'Or Institute for Research and Education
Impact of Adjuvant Chemotherapy in Patients With Colon Cancer	NCT03213444	Colon Cancer Adjuvant Chemot...	adjuvant chemot... adjuvant chemot...	30 Years - 75 Years	University of Sao Paulo General Hospital
The Impact of Chronic Mitochondrial Antioxidant Supplementation on CardiovascularToxicity in Breast Cancer Patients	NCT05146843	Breast Neoplasm...	Mitoquinone Placebo	18 Years - 75 Years	D'Or Institute for Research and Education
Impact of Adjuvant Chemotherapy in Patients With Colon Cancer	NCT03213444	Colon Cancer Adjuvant Chemot...	adjuvant chemot... adjuvant chemot...	30 Years - 75 Years	University of Sao Paulo General Hospital

Spots Global Cancer Trial Database for peripheral vascular function