Metabolism, body composition and sleep‑wake rhythms in return of periods after chemotherapy
Official title: Impact of Metabolic Status and Circadian Rhythms on Post-chemotherapy Ovarian Recovery in Women Treated for Breast Cancer
Run by University Hospital, Lille · NCT05007834 · Data updated 2026-11-12
This project will test whether metabolism, muscle and fat stores, activity level and your sleep‑wake pattern affect how and when periods come back in women aged 25–35 who developed chemotherapy‑induced amenorrhea after FEC100 plus docetaxel.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 25 Years to 35 Years |
| Sex | Women only |
| Enrollment | 50 (estimated) |
| Sponsor | University Hospital, Lille Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Lille) |
| Status | Recruiting |
| Started | February 24, 2022 |
| Main results expected | June 2026 |
| Study ends | June 2026 |
| Registry record updated | December 26, 2025 |
| Trial ID | NCT05007834 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 25–35 with chemotherapy‑induced amenorrhea after FEC100 (3 cycles) followed by docetaxel (3 cycles) who seek post‑cancer fertility follow‑up at CHU Lille.
✕Probably not a fit
Women older than 35, those without CIA, or those treated with different chemotherapy regimens are unlikely to gain direct prognostic benefit from this study's findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational project follows women aged 25–35 who developed chemotherapy‑induced amenorrhea after a defined breast cancer regimen (FEC100 ×3 then docetaxel ×3) at the University Hospital of Lille. Researchers will measure metabolic indicators, body composition (muscle and adipose tissue), physical activity and chronotype alongside reproductive markers such as AMH and menstrual history. Participants will be followed over time to record return of ovarian function (menstrual resumption and hormonal markers) without any experimental treatment. The goal is to see if energy reserves and daily rhythms predict timing of ovarian recovery and could help personalize fertility counseling.
Why it matters
Potential benefit: If successful, the findings could help predict who will regain menstrual function sooner and guide personalized fertility counseling and follow‑up after chemotherapy.
How similar studies have gone: Prior work shows that younger age, lower gonadotoxic regimens and higher pre‑chemotherapy AMH predict faster menstrual recovery, but linking metabolism, body composition and chronotype to ovarian recovery is relatively novel and not yet established.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Hop Jeanne de Flandre Chu Lille
Lille, France Recruiting
Study contacts
- Principal investigator: Pascal PIGNY, MD,PhD — University Hospital, Lille
- Study coordinator: Pascal PIGNY, MD,PhD
- Email: pascal.pigny@chru-lille.fr
- Phone: 0320445962
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.