Clinical trial · Observational
Metabolism, Circadian Rhythms and Ovarian Function
Impact of Metabolic Status and Circadian Rhythms on Post-chemotherapy Ovarian Recovery in Women Treated for Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy-Induced Amenorrhea | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Concentration of IL-6 levels at the end of chemotherapy
- timeFrame
- 1 year
- description
- 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 outcomes (11)
- measure
- Correlation between blood metabolic markers (Leptin, Insulin, Ghrelin) and menstrual period return state
- timeFrame
- 1 year
- description
- Leptin concentration in ng/ml; insulin concentration in mUI/L; ghrelin concentrations in pg/ml
- measure
- Correlation between physical activity score at the end of chemotherapy and menstrual period return state
- timeFrame
- 1 year
- description
- Physical activity score expressed in arbitrary units
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 35 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available