RecruitingOBSERVATIONAL

Metabolism, Circadian Rhythms and Ovarian Function

This study is exploring why some women's periods return after chemotherapy for breast cancer, while for others they don't. Chemotherapy can sometimes stop periods, which affects a woman's fertility. We know that being younger, having milder chemotherapy, or higher hormone levels before treatment might help periods return. This research wants to see if other things play a part, like your body's energy use, your daily sleep and wake patterns (circadian rhythms), and how active you are. By understanding these factors, doctors hope to better predict who might recover their fertility and give more accurate information to women affected by breast cancer treatment.

At a glance

Status

Recruiting

Sponsor

University Hospital, Lille

Enrolment target

Start

24 Feb 2022

Estimated completion

01 Jun 2026

Chemotherapy-Induced Amenorrhea

What is this study about?

Chemotherapy, a common treatment for cancer, can sometimes have a significant side effect on women's reproductive health. One of these effects is called 'chemo-induced amenorrhea' (CIA), which simply means that periods stop due to the chemotherapy. This can be temporary or long-lasting and directly impacts a woman's ability to have children if she wishes to do so in the future.

While doctors currently have some ideas about what might help periods come back faster – for example, being younger when you get diagnosed, having less harsh chemotherapy, or having higher levels of a specific hormone (AMH) before treatment – it's still difficult to predict accurately. There's also some debate about whether having a higher body mass index (BMI) helps, but more research is needed to be sure.

This particular study aims to look at some new possible factors. Researchers want to understand if your body's energy levels, your natural daily routines (like when you sleep and wake up), and how much physical activity you do might influence whether your periods return after chemotherapy. By studying these elements in women who have had breast cancer and experienced CIA, the goal is to gain a clearer picture of how ovarian function can recover. Ultimately, this information could help doctors provide better advice and support to women facing fertility concerns after cancer treatment.

Key takeaways

This study investigates why periods return for some women after chemotherapy.
It focuses on women aged 25-35 with breast cancer whose periods stopped due to specific chemotherapy.
Researchers are looking at your body’s metabolism, daily rhythms, and exercise.
The goal is to better predict who might recover their fertility post-treatment.
Participation would involve assessments and follow-up at the University Hospital of Lille.

Who may be eligible?

This study is looking for women who meet specific criteria. You would need to be between 25 and 35 years old when you join the study. Importantly, your periods must have stopped because of chemotherapy and you should have already asked for follow-up care for your fertility at the University Hospital of Lille in France.

The chemotherapy you received must have been a specific type: three cycles of FEC 100 followed by three cycles of docetaxel. If you received a different chemotherapy plan, unfortunately, you wouldn't be able to take part in this particular study.

Also, if your periods have already returned, or if you simply don't want to participate, then this study isn't for you. The researchers need to focus on a very specific group of women to ensure they get clear and useful results.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman whose periods stopped due to chemotherapy?
Were you between 25 and 35 years old when you considered joining this study?
Did you receive FEC 100 (3 cycles) + docetaxel (3 cycles) chemotherapy?
Have you already sought fertility follow-up at the University Hospital of Lille, France?

Answer every question to see your result.

What does participation involve?

The detailed information about what taking part involves isn't provided in the summary. However, based on the study's aim, it would likely involve several visits to the University Hospital of Lille over a period. These visits might include blood tests to check hormone levels and metabolism, questionnaires about your physical activity and sleep patterns, and possibly measurements of your body composition. The study is trying to understand changes over time, so you would probably be followed up regularly. The total duration of participation is not mentioned, but studies like this can often last for several months or even a year or two.

Potential risks and benefits

Taking part in a study like this provides information that could help many women in the future, especially those concerned about fertility after cancer. There are no direct medical benefits mentioned for participants, as this is an observational study rather than a trial of a new treatment. Potential risks might include the time commitment for appointments and any minor discomfort from blood tests. You would always have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Hop Jeanne de Flandre Chu Lille
Verified postcode
Lille, France· Recruiting

Common questions

What does 'chemo-induced amenorrhea' mean?

It means your periods have stopped because of chemotherapy treatment for cancer.

What are 'circadian rhythms'?

These are your body's natural daily cycles, like your sleep-wake pattern, that happen over about 24 hours.

Why is this study important?

It aims to help doctors better understand why some women's periods return after chemotherapy, which can help fertility planning.

Will taking part in this study cure my amenorrhea?

No, this study is about understanding the problem, not testing a new treatment or cure. It's an observational study.

Can men participate in this study?

No, this study is specifically for women, as it focuses on ovarian function and periods.

How to find out more

Pascal PIGNY, MD,PhD

pascal.pigny@chru-lille.fr 0320445962 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.