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A randomized, controlled, phase II clinical trial of ß-D-mannuronic acid (M2000) in pre-surgical breast cancer patients at early stage (T1-T2).
Kashefi, Sarvenaz; Omranipour, Ramesh; Mahmoodzadeh, Habibollah; Ahmadi, Hamid; Alikhassi, Afsaneh; Hosseini, Mostafa; Cuzzocrea, Salvatore; Rehm, Bernd H A; Matsuo, Hidenori; Mirshafiey, Abbas.
Afiliação
  • Kashefi S; Department of Immunology, School of Public Health, Tehran University of Medical Science, Tehran, Iran.
  • Omranipour R; Breast Disease Research Centre (BDRC), Tehran University of Medical Sciences, Tehran, Iran.
  • Mahmoodzadeh H; Department of Surgical Oncology, Tehran University of Medical Science, Tehran, Iran.
  • Ahmadi H; Department of Surgical Oncology, Tehran University of Medical Science, Tehran, Iran.
  • Alikhassi A; Breast Disease Research Centre (BDRC), Tehran University of Medical Sciences, Tehran, Iran.
  • Hosseini M; Department of Radiology, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran.
  • Cuzzocrea S; Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.
  • Rehm BHA; Department of Chemical, Biological, Pharmaceutical and Environmental Sciences, University of Messina, Messina, Italy.
  • Matsuo H; Centre for Cell Factories and Biopolymers, Griffith Institute for Drug Discovery, Griffith University, Nathan, Queensland, Australia.
  • Mirshafiey A; National Hospital Organization, Nagasaki National Hospital, Nagasaki, Japan.
Clin Exp Pharmacol Physiol ; 46(6): 527-532, 2019 06.
Article em En | MEDLINE | ID: mdl-30887570
Following the potent efficacy of ß-D-Mannuronic acid in a breast cancer murine model, we evaluated the efficacy of this novel non-steroidal anti-inflammatory drug in breast cancer patients in the present clinical trial. The study was an 8-week randomized, controlled, phase II clinical trial (IRCT: 2017012213739N7 (in 48 pre-surgical breast cancer patients. Patients who had breast cancer at early stage, with invasive ductal carcinoma, were placed on a waiting-list for surgery and were allocated to the study. ß-D-Mannuronic was administrated at a dose of two capsules (1000 mg/d) orally during a period of 8 weeks. The end point of this study was when the patients were admitted for surgery. Moreover, the patients' well-being status was followed up on for safety. There were no statistically significant differences between treatment and non-treatment groups at baseline. ß-D-Mannuronic acid therapy, from 20 patients, showed that in one patient (5%) tumour size was decreased; in five patients (25%) tumour growth was stopped; and in 14 patients (70%) the growth rate in the treatment group did not show significant change, compared to the non-treatment group. Evaluation of two tumour markers (carcinoembryonic antigen and cancer antigen 15-3) showed that there was no significant difference between before and after treatment. Although the use of some non-steroidal anti-inflammatory drugs in a long time period has shown a prophylactic effect in breast cancer, their therapeutic efficacy in a short time period is unknown, whereas treatment with ß-D-Mannuronic acid during 8 weeks could show 30% therapeutic effects in pre-surgical breast cancer patients.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Neoplasias da Mama / Ácidos Hexurônicos Tipo de estudo: Clinical_trials Limite: Female / Humans / Middle aged Idioma: En Ano de publicação: 2019 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Neoplasias da Mama / Ácidos Hexurônicos Tipo de estudo: Clinical_trials Limite: Female / Humans / Middle aged Idioma: En Ano de publicação: 2019 Tipo de documento: Article