Department of Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, National Clinical Research Center for Obstetrical and Gynecological Diseases, Wuhan, 430030, Hubei, China.
Department of Thyroid and Breast Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.
Maturitas. 2020 Jul;137:1-6. doi: 10.1016/j.maturitas.2020.04.010. Epub 2020 Apr 21.
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.
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.
Our research will provide a new treatment strategy for fertility protection, and clinical treatment guidance for cancer patients.
随着癌症患者治愈率和生存率的显著提高，幸存者面临着生活质量问题，例如生殖系统发育、卵巢储备和功能显著下降，甚至丧失生育能力和提前绝经。这些问题通常与癌症治疗中化疗引起的卵巢损伤高度相关。然而，目前没有理想的治疗策略。在我们尝试开发用于延缓卵巢衰老和保护化疗引起的卵巢损伤的试剂和方法时，我们最近发现二甲双胍可能是保护女性恶性肿瘤患者免受化疗引起的卵巢损伤的最有前途的药物。本试验旨在测试化疗期间给予二甲双胍是否可以保护早期乳腺癌患者的正常卵巢功能。
本研究为前瞻性、随机、双盲、安慰剂对照。将 314 例早期乳腺癌女性患者随机分为两组（安慰剂、二甲双胍 2000mg）。I-IIIa 期乳腺癌患者在化疗期间和化疗后给予二甲双胍。主要结局是化疗后 12 个月的月经恢复率，定义为 1 年内连续两次恢复月经。将对患者进行 5 年随访，以观察长期卵巢功能和预后，如总生存期（OS）、客观缓解率（ORR）和无病生存期（DFS）。还将评估生活质量和安全性。
我们的研究将为生育保护提供新的治疗策略，并为癌症患者提供临床治疗指导。
