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Recruiting NCT05007834

Metabolism, Circadian Rhythms and Ovarian Function

— Observational Chemotherapy-Induced Amenorrhea

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Chemotherapy-Induced Amenorrhea. Basic parameters: 25 years — 35 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

Primary outcome measures

  • Concentration of IL-6 levels at the end of chemotherapy [Time frame: 1 year]
Secondary outcome measures (11)
  • Correlation between blood metabolic markers (Leptin, Insulin, Ghrelin) and menstrual period return state [Time frame: 1 year]
  • Correlation between physical activity score at the end of chemotherapy and menstrual period return state [Time frame: 1 year]
  • Correlation between chronotype score at the end of chemotherapy and menstrual period return state [Time frame: 1 year]
  • Correlation between the BMI at the end of chemotherapy and menstrual period return state [Time frame: 1 year]
  • Correlation between Blood metabolic markers (Leptin, Insulin, Ghrelin) assessed at 3 months and menstrual period return state [Time frame: 9 months]
  • Correlation between the Physical activity Score at 3 months and the menstrual period return state (between 3 to 12 months) [Time frame: 9 months]
  • Correlation between the BMI assessed at 3 months and the menstrual period return state (between 3 to 12 months) [Time frame: 9 months]
  • Evolution of the blood concentration of insulin over the follow-up period (12 months) [Time frame: 1 year]
  • Correlation between the Chronotype Score at 3 months and the menstrual period return state (between 3 to 12 months) [Time frame: 9 months]
  • Evolution of the blood concentration of Leptin over the follow-up period (12 months) [Time frame: 1 year]
  • Evolution of the blood concentration of Ghrelin over the follow-up period (12 months) [Time frame: 1 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Hop Jeanne de Flandre Chu Lille — Lille

Identifiers

NCT: NCT05007834 · 2020_16 · 2021-A00461-40

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗