Metformin intervention against ovarian toxicity during chemotherapy for early breast cancer: Study protocol for a randomized double-blind placebo-controlled trial.
Maturitas
; 137: 1-6, 2020 Jul.
Article
em En
| MEDLINE
| ID: mdl-32498930
ABSTRACT
BACKGROUND:
With the significant improvement of the cure rate and survival rate of cancer patients, the survivors face quality-of-life problems, such as a significant decline in reproductive system development, ovarian reserves and function, and even fertility loss and early menopause. These problems are often highly associated with chemotherapy-induced ovarian damage in cancer treatment. However, there are no ideal treatment strategies at present. In our attempt to develop reagents and approaches for delaying ovarian aging and protecting chemotherapy-induced ovarian injury, we recently found that metformin may be the most promising drug to protect female malignant tumor patients from chemotherapy-induced ovarian injury. This trial aims to test whether administration of metformin during chemotherapy can protect the normal ovarian function of patients with early breast cancer.METHODS:
This study is prospective, randomized, double-blind and placebo-controlled. Female patients with early breast cancer (N = 314) will be randomly assigned to two groups (placebo, metformin 2000 mg). Metformin will be administered during and after chemotherapy for patients with stage I-IIIa breast cancer. The primary outcome will be the menstruation recovery rate 12 months after chemotherapy, defined as recovery of menstruation twice in a row within 1 year. Patients will be followed up for 5 years to observe long-term ovarian function and prognosis, such as overall survival (OS), objective response rate (ORR), and disease-free survival (DFS). Quality of life and safety will also be assessed.DISCUSSION:
Our research will provide a new treatment strategy for fertility protection, and clinical treatment guidance for cancer patients.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Ovário
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Neoplasias da Mama
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Protocolos de Quimioterapia Combinada Antineoplásica
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Hipoglicemiantes
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Menstruação
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Metformina
Tipo de estudo:
Clinical_trials
/
Guideline
/
Observational_studies
/
Risk_factors_studies
Aspecto:
Patient_preference
Limite:
Adolescent
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Adult
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Female
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Humans
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Middle aged
Idioma:
En
Revista:
Maturitas
Ano de publicação:
2020
Tipo de documento:
Article
País de afiliação:
China