METAB-OV: Metabolism, Circadian Rhythms and Ovarian Function

Sponsor

University Hospital, Lille (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05007834

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Chemotherapy-Induced Amenorrhea

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2025

Anticipated Study Completion Date :

Sep 1, 2025

Outcome Measures

Primary Outcome Measures

Concentration of IL-6 levels at the end of chemotherapy [1 year]
Study the association between the IL-6 blood levels (in pg/ml) at the end of chemotherapy and the menstrual period return state ( before or after 6 months)

Secondary Outcome Measures

Correlation between blood metabolic markers (Leptin, Insulin, Ghrelin) and menstrual period return state [1 year]
Leptin concentration in ng/ml; insulin concentration in mUI/L; ghrelin concentrations in pg/ml
Correlation between physical activity score at the end of chemotherapy and menstrual period return state [1 year]
Physical activity score expressed in arbitrary units
Correlation between chronotype score at the end of chemotherapy and menstrual period return state [1 year]
chronotype score expressed in arbitrary units
Correlation between the BMI at the end of chemotherapy and menstrual period return state [1 year]
weight and height will be combined to report BMI in kg/m2
Correlation between Blood metabolic markers (Leptin, Insulin, Ghrelin) assessed at 3 months and menstrual period return state [9 months]
Leptin concentration in ng/ml, Insulin concentration in mUI/L, Ghrelin concentration in pg/ml
Correlation between the Physical activity Score at 3 months and the menstrual period return state (between 3 to 12 months) [9 months]
Physical activity score expressed in arbitrary units
Correlation between the BMI assessed at 3 months and the menstrual period return state (between 3 to 12 months) [9 months]
weight and height assessed at 3 months will be combined to report BMI in kg/m2
Evolution of the blood concentration of insulin over the follow-up period (12 months) [1 year]
insulin concentrations expressed in mUI/L
Correlation between the Chronotype Score at 3 months and the menstrual period return state (between 3 to 12 months) [9 months]
chronotype score expressed in arbitrary units
Evolution of the blood concentration of Leptin over the follow-up period (12 months) [1 year]
leptin concentrations expressed in ng/ml
Evolution of the blood concentration of Ghrelin over the follow-up period (12 months) [1 year]
ghrelin concentrations expressed in pg/ml

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts 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