A randomized, controlled, phase II clinical trial of β-D-mannuronic acid (M2000) in pre-surgical breast cancer patients at early stage (T1-T2).

Abstract

Following the potent efficacy of β-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. β-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. β-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 β-D-Mannuronic acid during 8 weeks could show 30% therapeutic effects in pre-surgical breast cancer patients.

• Authors: Sarvenaz Kashefi, Ramesh Omranipour, Habibollah Mahmoodzadeh, Hamid Ahmadi, Afsaneh Alikhassi, Mostafa Hosseini, Salvatore Cuzzocrea, Bernd H A Rehm, Hidenori Matsuo, Abbas Mirshafiey
• Journal: Clinical and experimental pharmacology & physiology (Clin Exp Pharmacol Physiol) Vol. 46 Issue 6 Pg. 527-532 (06 2019) ISSN: 1440-1681 [Electronic] Australia
• PMID: 30887570 (Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial)
• Copyright: © 2019 John Wiley & Sons Australia, Ltd.

Chemical References

• Hexuronic Acids
• mannuronic acid

Topics

• Breast Neoplasms (drug therapy, pathology, surgery)
• Female
• Hexuronic Acids (adverse effects, therapeutic use)
• Humans
• Middle Aged
• Neoplasm Staging
• Safety