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

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

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

Study Overview

• Status: Recruiting
• Conditions: Chemotherapy-Induced Amenorrhea

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Pascal PIGNY, MD,PhD; Phone Number: +33 0320445962; Email: pascal.pigny@chru-lille.fr

Study Locations

• France
  • Lille, France
    • Recruiting
    • Hop Jeanne de Flandre Chu Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of IL-6 levels at the end of chemotherapy	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)	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Pascal PIGNY, MD,PhD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2022
• Primary Completion (Anticipated): February 1, 2025
• Study Completion (Anticipated): February 1, 2025

Study Registration Dates

• First Submitted: May 20, 2021
• First Submitted That Met QC Criteria: August 9, 2021
• First Posted (Actual): August 16, 2021

Study Record Updates

• Last Update Posted (Actual): March 3, 2023
• Last Update Submitted That Met QC Criteria: March 2, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Adipose tissue; Metabolism; Chronotype; Muscular mass; Ovarian recovery
• Additional Relevant MeSH Terms: Pathologic Processes; Menstruation Disturbances; Amenorrhea
• Other Study ID Numbers: 2020_16; 2021-A00461-40 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No