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Metabolism, Circadian Rhythms and Ovarian Function (METAB-OV)

U

University Hospital, Lille

Status

Enrolling

Conditions

Chemotherapy-Induced Amenorrhea

Study type

Observational

Funder types

Other

Identifiers

NCT05007834
2021-A00461-40 (Other Identifier)
2020_16

Details and patient eligibility

About

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

Enrollment

50 estimated patients

Sex

Female

Ages

25 to 35 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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 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

Trial contacts and locations

1

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Central trial contact

Pascal PIGNY, MD,PhD

Data sourced from clinicaltrials.gov

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