Clinical trial NCT05007834: Metabolism, Circadian Rhythms and Ovarian Function
Official title: Impact of Metabolic Status and Circadian Rhythms on Post-chemotherapy Ovarian Recovery in Women Treated for Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chemotherapy-Induced Amenorrhea
Keywords: Ovarian recovery
Metabolism
Muscular mass
Adipose tissue
Chronotype
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2021-08-16
Enrollment: 50
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with a chemotherapy-induced (CIA) amenorrhea who asked for post-cancer fertility follow-up at the University Hospital of Lille, France.

Brief 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 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

Primary outcomes:
measure: Concentration of IL-6 levels at the end of chemotherapy
timeFrame: 1 year
Secondary outcomes:
measure: Correlation between blood metabolic markers (Leptin, Insulin, Ghrelin) and menstrual period return state
timeFrame: 1 year
measure: Correlation between physical activity score at the end of chemotherapy and menstrual period return state
timeFrame: 1 year
measure: Correlation between chronotype score at the end of chemotherapy and menstrual period return state
timeFrame: 1 year
measure: Correlation between the BMI at the end of chemotherapy and menstrual period return state
timeFrame: 1 year
measure: Correlation between Blood metabolic markers (Leptin, Insulin, Ghrelin) assessed at 3 months and menstrual period return state
timeFrame: 9 months
measure: Correlation between the Physical activity Score at 3 months and the menstrual period return state (between 3 to 12 months)
timeFrame: 9 months
measure: Correlation between the BMI assessed at 3 months and the menstrual period return state (between 3 to 12 months)
timeFrame: 9 months
measure: Evolution of the blood concentration of insulin over the follow-up period (12 months)
timeFrame: 1 year
measure: Correlation between the Chronotype Score at 3 months and the menstrual period return state (between 3 to 12 months)
timeFrame: 9 months
measure: Evolution of the blood concentration of Leptin over the follow-up period (12 months)
timeFrame: 1 year
measure: Evolution of the blood concentration of Ghrelin over the follow-up period (12 months)
timeFrame: 1 year
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Jeanne de Flandre Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: Pascal PIGNY, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: