Metabolism, Circadian Rhythms and Ovarian Function

Last updated: March 2, 2023
Sponsor: University Hospital, Lille
Overall Status: Active - Recruiting

Phase

N/A

Condition

Amenorrhea

Treatment

N/A

Clinical Study ID

NCT05007834
2020_16
2021-A00461-40
  • Ages 25-35
  • Female

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Women with a chemotherapy-induced (CIA) amenorrhea who asked for post-cancer fertilityfollow-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

Exclusion

Exclusion Criteria:

  • Women without CIA
  • Women who refuse to participate in the study
  • Women older than 35 years at inclusion
  • Women who received another chemotherapy protocol

Study Design

Total Participants: 50
Study Start date:
February 24, 2022
Estimated Completion Date:
February 28, 2025

Connect with a study center

  • Hop Jeanne de Flandre Chu Lille

    Lille,
    France

    Active - Recruiting

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