RecruitingNCT05007834

Metabolism, Circadian Rhythms and Ovarian Function

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


Sponsor

University Hospital, Lille

Enrollment

50 participants

Start Date

Feb 24, 2022

Study Type

OBSERVATIONAL

Conditions

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

Sex: FEMALEMin Age: 25 YearsMax Age: 35 Years

Inclusion Criteria3

  • 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

Exclusion Criteria4

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

Locations(1)

Hop Jeanne de Flandre Chu Lille

Lille, France

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NCT05007834