AuthorisedTherapeutic confirmatory (Phase III)Interventional

A phase III Randomized Double-Blinded Placebo-Controlled Study of Use of GnRHa during Chemotherapy for Fertility Protection of Young Women and Teenagers with Cancer - ProFertil

This important study, called ProFertil, is investigating a drug called GnRHa to see if it can help protect the fertility of young women and teenagers receiving chemotherapy for cancers like breast cancer, leukaemia, lymphoma, and sarcoma. Chemotherapy can sometimes harm the ovaries, making it harder to have children later. Researchers want to find out if GnRHa can reduce this damage. Participants will either receive GnRHa or a placebo (a dummy treatment) alongside their chemotherapy. The main goal is to compare levels of a hormone called AMH, which indicates ovarian health, 12 months after chemotherapy finishes. The study also looks at other signs of ovarian function over several years.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Karolinska University Hospital

Enrolment target

500

Start

25 Oct 2024

Breast Cancer Acute Leukemia Lymphomas (Hodgkin and non-Hodgkin) ans Sarcomas (Osteo Soft tissue and Ewing)

What is this study about?

This study, called ProFertil, is designed for young women and teenagers who are about to start chemotherapy for specific types of cancer, including breast cancer, acute leukaemia, lymphomas, and sarcomas. We know that chemotherapy, while vital for treating cancer, can sometimes have an unwanted side effect: it can harm the ovaries. The ovaries are responsible for producing eggs and hormones, so damage to them can affect a woman's ability to have children in the future, a concern we call fertility.

The main aim of this study is to see if a particular medication, called GnRHa (which stands for Gonadotropin-Releasing Hormone agonist), can help protect the ovaries from chemotherapy damage. GnRHa works by temporarily putting the ovaries into a 'sleep' state during chemotherapy, which might make them less vulnerable. In this study, some participants will receive GnRHa along with their chemotherapy, while others will receive a 'placebo', which is a dummy treatment that looks just like GnRHa but contains no active medicine. This allows researchers to fairly compare the effects of the drug.

The researchers will be closely monitoring how well the ovaries are working after chemotherapy. They'll mainly do this by measuring a hormone called AMH (Anti-Müllerian Hormone) in the blood, which is a good indicator of how many eggs a woman has left in her ovaries. They will also look at other things like periods, hormone levels, and ultrasound scans of the ovaries over several years to get a full picture of fertility preservation. This research is incredibly important because it could lead to new ways of helping young cancer patients maintain their chances of having a family in the future.

Key takeaways

This study explores a potential treatment to protect fertility during chemotherapy.
It involves young women (18+) with certain cancers like breast cancer, leukaemia, or lymphoma.
Participants will receive either an active drug (GnRHa) or a dummy treatment (placebo).
Researchers will monitor ovarian health and hormone levels for up to five years.
The goal is to see if GnRHa helps preserve the ability to have children after chemotherapy.

Who may be eligible?

This study is looking for women aged 18 and over. While the study mentions "young women and teenagers," for this particular trial, participants must be at least 18 years old. There is no upper age limit.

You would be considered for this study if you have recently been diagnosed with certain types of cancer, specifically breast cancer, acute leukaemia, lymphoma (Hodgkin or non-Hodgkin), or sarcoma (including osteosarcoma, soft tissue sarcoma, and Ewing sarcoma).

Other specific medical details will be checked by the study team to ensure the trial is safe and appropriate for you, but these are the main starting points for eligibility.

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 18 years old or older?
Do you have breast cancer, acute leukaemia, lymphoma, or sarcoma?
Are you about to start chemotherapy?
Are you able to attend regular follow-up appointments and have blood tests for several years?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the GnRHa medication or a placebo (dummy treatment) through an injection, alongside your regular chemotherapy. The study team will make sure that neither you nor your doctors know which treatment you are receiving – this is called 'double-blinded' and helps ensure the results are fair.

You would have blood tests at the start of the study, at the end of your chemotherapy, and then regularly for up to five years afterwards. These blood tests will measure hormone levels like AMH, FSH, inhibin, and estradiol. You might also have ultrasound scans to check your ovaries and blood flow, and the study team will track your menstrual cycles.

The total duration of your active participation, including follow-up, could be up to five years to assess the long-term impact on your fertility.

Potential risks and benefits

Taking part in this study might offer a potential benefit of protecting your fertility during chemotherapy, which is a significant concern for many young cancer patients. However, there's no guarantee that the drug will work for everyone, and it's also possible you could receive the placebo. Like all medicines, GnRHa can have side effects, and your medical team will discuss these with you. You are always free to withdraw from the study at any time, for any reason, without it affecting your standard medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Sweden

Common questions

What does 'fertility protection' mean in this study?

It means trying to stop chemotherapy from harming your ovaries, so you might still be able to have children after your cancer treatment is over.

What is a 'placebo'?

A placebo is a dummy treatment that looks just like the real medicine but contains no active ingredients. It's used to fairly compare the effects of the actual drug.

What is AMH and why is it being measured?

AMH is a hormone in your blood that helps doctors estimate how many eggs you have left in your ovaries. It's a way to check on your ovarian health.

Will I know if I'm getting the active drug or the placebo?

No, this is a 'double-blinded' study, meaning neither you nor your doctors will know which treatment you are receiving until after the study is complete. This makes the results more reliable.

How long will I be involved in the study?

Your involvement in the study, including follow-up appointments, could last for up to five years after your chemotherapy finishes.