Chemotherapy-Induced Amenorrhea
Conditions
Keywords
Ovarian recovery, Metabolism, Muscular mass, Adipose tissue, Chronotype
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
Interventions
None listed
Sponsors
University Hospital, Lille
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 35 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 |
| 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 |
Countries
France
Contacts
Primary ContactPascal PIGNY, MD,PhD
Outcome results
None listed