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

    Author(s)
    Kashefi, S
    Omranipour, R
    Mahmoodzadeh, H
    Ahmadi, H
    Alikhassi, A
    Hosseini, M
    Cuzzocrea, S
    Rehm, BHA
    Matsuo, H
    Mirshafiey, A
    Griffith University Author(s)
    Rehm, Bernd
    Year published
    2019
    Metadata
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    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 ...
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    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.
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    Journal Title
    Clinical and Experimental Pharmacology and Physiology
    Volume
    46
    Issue
    6
    DOI
    https://doi.org/10.1111/1440-1681.13086
    Subject
    Zoology
    Pharmacology and pharmaceutical sciences
    Medical physiology
    Publication URI
    http://hdl.handle.net/10072/384596
    Collection
    • Journal articles

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