RecruitingNAINTERVENTIONAL

Bariatric Surgery for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium

This study is for young women, aged 18 to 41, who have early womb cancer (endometrial cancer) or a pre-cancerous condition called atypical hyperplasia, and who also have obesity. These conditions are becoming more common in younger women due to rising obesity rates. Currently, hormone treatment (like a special coil) is used to help these women keep their fertility, but it doesn't always work well. This trial will explore if weight-loss surgery, alongside hormone treatment, could be a more effective and lasting solution. It hopes to improve outcomes for women who wish to have children in the future, by addressing the underlying obesity.

At a glance

Status

Recruiting

Phase

Sponsor

University Health Network, Toronto

Enrolment target

Start

14 May 2021

Estimated completion

31 Mar 2027

Endometrial Cancer Atypical Hyperplasia Bariatric Surgery Candidate

What is this study about?

Womb cancer, also known as endometrial cancer, and a condition called atypical hyperplasia (where cells in the womb lining become abnormal and could turn into cancer) are unfortunately becoming more common, especially in younger women. This is largely linked to the increasing rates of obesity.

For young women who are diagnosed with these conditions and want to be able to have children in the future, the usual treatment is hormone therapy, often given through a special coil (like a Mirena coil). However, this treatment doesn't always completely get rid of the abnormal cells, and for many women, the problem comes back after a while. This is because the hormone therapy doesn't address the main reason why the cancer or pre-cancer developed in the first place, which is often related to obesity.

This study aims to discover if significant weight loss through weight-loss (bariatric) surgery, when combined with the standard hormone treatment, could lead to better and more lasting results. The researchers want to see if this approach is a sensible and acceptable option for young women who want to preserve their fertility. The study hopes to find a more effective way to treat these conditions while allowing women to potentially have a family in the future.

Key takeaways

This study is for young women with early womb cancer or a pre-cancerous condition.
It aims to find better ways to preserve fertility for women who also have obesity.
It compares standard hormone treatment with hormone treatment plus weight-loss surgery.
Obesity is a major risk factor for these conditions, and the study addresses this.
Participation involves being randomly assigned to one of two treatment groups.
You must be aged 18-41, have a BMI of 35 or higher, and specific types of condition.

Who may be eligible?

This study is looking for women aged between 18 and 41 years old. You might be suitable if you have been diagnosed with early-stage womb cancer (specifically, grade 1 endometrioid endometrial cancer) or a pre-cancerous condition called atypical hyperplasia, and if there's no sign of the disease having spread beyond your womb. You should also be keen to keep your ability to have children in the future.

To be eligible, you will need to have a Body Mass Index (BMI) of 35 or higher and be fit enough for surgery, without other serious health problems that would prevent it. You must not have had certain major abdominal surgeries in the past. It's also important that you don't use weight-loss medications currently, although certain diabetes medications like Ozempic are generally okay.

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 aged between 18 and 41?
Do you have a diagnosis of early womb cancer (Grade 1 endometrioid) or atypical hyperplasia?
Do you want to keep your ability to have children?
Is your Body Mass Index (BMI) 35 or higher?
Have you *not* had major stomach surgery before (like previous weight-loss surgery)?
Are you generally well enough for surgery and not currently pregnant?

Answer every question to see your result.

What does participation involve?

If you join this study, you will first go through a screening process to check if you are suitable. If you are, you will then be randomly assigned to one of two groups. This is like flipping a coin, so it's a fair chance for either group.

One group will receive the standard hormone treatment (the coil) along with weight-loss surgery. The other group will receive the standard hormone treatment (the coil) alone. Both groups will be carefully monitored to see how well their treatment works and how their health changes over time. The study will last over 21 months, and you will have regular check-ups and assessments during this period. We can't give you exact details for visits without specific study protocol, but expect regular appointments for monitoring and follow-up.

Potential risks and benefits

Taking part in any trial has potential benefits and risks. You might benefit from a potentially more effective treatment for your condition, which could improve your chances of preserving fertility. However, weight-loss surgery carries its own risks, like any surgical procedure, including infection, pain, and recovery time. The standard hormone treatment also has its own known side effects. You will be closely monitored throughout the study. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Princess Margaret Hospital
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is atypical hyperplasia?

Atypical hyperplasia is a condition where the cells lining your womb become abnormal. While not cancer yet, there's a higher chance they could turn into womb cancer if not treated.

What is bariatric surgery?

Bariatric surgery is a type of weight-loss surgery. It involves making changes to your digestive system to help you lose a significant amount of weight when other methods haven't worked.

Why is obesity linked to womb cancer?

Obesity can affect your hormone levels, particularly oestrogen. Higher oestrogen levels over time can encourage changes in the womb lining that may lead to cancer.

Will I still be able to have children after this treatment?

This study specifically focuses on treatments that aim to preserve your fertility. The goal is to treat your condition while keeping open the possibility of you having children in the future, but success cannot be guaranteed.

Will I have to pay for the surgery or hormone treatment?

No, if you are accepted into the study, all treatments, check-ups, and procedures directly related to the study will be provided at no cost to you.

How to find out more

Tara Zad

tara.zad@uhn.ca 416-946-4501 Official trial record

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