Идёт набор NCT05007834

Metabolism, Circadian Rhythms and Ovarian Function

— Наблюдательное Chemotherapy-Induced Amenorrhea

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Chemotherapy-Induced Amenorrhea. Базовые параметры: 25 лет — 35 лет · Женщины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Impact of Metabolic Status and Circadian Rhythms on Post-chemotherapy Ovarian Recovery in Women Treated for Breast Cancer

Обзор

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

Первичные конечные точки

Concentration of IL-6 levels at the end of chemotherapy [Срок оценки: 1 year]

Вторичные конечные точки (11)

Correlation between blood metabolic markers (Leptin, Insulin, Ghrelin) and menstrual period return state [Срок оценки: 1 year]
Correlation between physical activity score at the end of chemotherapy and menstrual period return state [Срок оценки: 1 year]
Correlation between chronotype score at the end of chemotherapy and menstrual period return state [Срок оценки: 1 year]
Correlation between the BMI at the end of chemotherapy and menstrual period return state [Срок оценки: 1 year]
Correlation between Blood metabolic markers (Leptin, Insulin, Ghrelin) assessed at 3 months and menstrual period return state [Срок оценки: 9 months]
Correlation between the Physical activity Score at 3 months and the menstrual period return state (between 3 to 12 months) [Срок оценки: 9 months]
Correlation between the BMI assessed at 3 months and the menstrual period return state (between 3 to 12 months) [Срок оценки: 9 months]
Evolution of the blood concentration of insulin over the follow-up period (12 months) [Срок оценки: 1 year]
Correlation between the Chronotype Score at 3 months and the menstrual period return state (between 3 to 12 months) [Срок оценки: 9 months]
Evolution of the blood concentration of Leptin over the follow-up period (12 months) [Срок оценки: 1 year]
Evolution of the blood concentration of Ghrelin over the follow-up period (12 months) [Срок оценки: 1 year]

Критерии участия

Критерии включения

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