Impact of Metabolic Status and Circadian Rhythms on Post-chemotherapy Ovarian Recovery in Women Treated for Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Concentration of IL-6 levels at the end of chemotherapy
研究概览
简要总结
Chemotherapy for cancer, due to its gonadotoxicity, can lead to impaired female fertility, resulting in the occurrence of transient or prolonged chemo-induced amenorrhea (CIA). According to recent data from the National Cancer Institute, 11.9% of women under the age of 40 diagnosed with cancer have been offered a fertility evaluation within five years of diagnosis. Predicting the risk and especially the duration of the CIA remains difficult. Known factors predicting a rapid return of menstruation are a young age at diagnosis, a low gonadotoxic treatment (absence of alkylating agents) and a high pre-chemotherapy blood level of AMH reflecting a large pool of growing follicles. A body mass index (BMI) ≥ 25 kg / m² could also be a positive predictor, but this remains debated.
The objective of this project is to assess the impact of metabolism and energy reserves, physical activity and the chronotype on the recovery of ovarian function in patients with breast cancer who have developed CIA
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with a chemotherapy-induced (CIA) amenorrhea who asked for post-cancer fertility follow-up at the University Hospital of Lille, France.
- •Women between 25 to 35 years age at inclusion
- •Chemotherapy protocol: FEC 100 (3 cycles) + docetaxel (3 cycles
排除标准
- •Women without CIA
- •Women who refuse to participate in the study
- •Women older than 35 years at inclusion
- •Women who received another chemotherapy protocol
结局指标
主要结局
Concentration of IL-6 levels at the end of chemotherapy
时间窗: 1 year
Study the association between the IL-6 blood levels (in pg/ml) at the end of chemotherapy and the menstrual period return state ( before or after 6 months)
次要结局
- Correlation between blood metabolic markers (Leptin, Insulin, Ghrelin) and menstrual period return state(1 year)
- Correlation between chronotype score at the end of chemotherapy and menstrual period return state(1 year)
- Correlation between the Physical activity Score at 3 months and the menstrual period return state (between 3 to 12 months)(9 months)
- Correlation between physical activity score at the end of chemotherapy and menstrual period return state(1 year)
- Correlation between the BMI at the end of chemotherapy and menstrual period return state(1 year)
- Correlation between Blood metabolic markers (Leptin, Insulin, Ghrelin) assessed at 3 months and menstrual period return state(9 months)
- Evolution of the blood concentration of insulin over the follow-up period (12 months)(1 year)
- Correlation between the BMI assessed at 3 months and the menstrual period return state (between 3 to 12 months)(9 months)
- Correlation between the Chronotype Score at 3 months and the menstrual period return state (between 3 to 12 months)(9 months)
- Evolution of the blood concentration of Leptin over the follow-up period (12 months)(1 year)
- Evolution of the blood concentration of Ghrelin over the follow-up period (12 months)(1 year)