AuthorisedTherapeutic exploratory (Phase II)Interventional

Early intervention and recovery of sexual function in men and women after treatment of rectal cancer–a randomized controlled study with tadalafil compared to standard care

This research is investigating whether a medication called Cialis could help improve sexual function for both men and women after they have received treatment for bowel cancer. Bowel cancer treatment, especially surgery, can sometimes affect sexual health, and this study aims to see if Cialis can make a positive difference. Researchers will compare people taking a small dose of Cialis to those receiving the usual care, over a period of two years. They will look at changes in sexual function, physical healing, hormone levels, and overall well-being. The goal is to find better ways to support patients in their recovery and quality of life after cancer treatment.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Karolinska Institutet

Enrolment target

Start

27 Sep 2024

sexual/ erectile function in women and men after treatment for rectal cancer

What is this study about?

When people have treatment for bowel cancer (also known as rectal cancer), it can sometimes have an impact on their sexual health. This can be a sensitive topic, but it's important to understand that it's a common concern for many patients.

This study is looking into whether a medication called Cialis, which is already used to treat erectile dysfunction, could also help improve sexual function for both men and women after their bowel cancer treatment. Researchers want to compare how people who take a small daily dose of Cialis feel compared to those who receive standard care (meaning they don't take Cialis for this study).

The main aim is to see if Cialis can lead to better sexual function over two years. But the study will also look at other important things, like how the body heals (for example, looking at any scarring or changes in genital tissues), hormone levels, and overall quality of life. The hope is to find ways to help people recover more fully and improve their well-being after going through cancer treatment.

Key takeaways

This study explores Cialis's role in improving sexual function after bowel cancer treatment.
It involves both men and women aged 18 and over.
Participation lasts two years with regular check-ups and questionnaires.
You might receive Cialis or standard care; neither you nor your doctor will know which.
Aims to improve quality of life and understanding of recovery after cancer.

Who may be eligible?

This study is open to both men and women. To take part, you need to be at least 18 years old. There's no upper age limit, so adults of any age can be considered.

To be eligible, you must have recently had or be about to have treatment for bowel (rectal) cancer. The researchers are looking for people who might be experiencing, or are at risk of experiencing, changes in their sexual function after this treatment.

There will be other detailed medical checks to make sure the study is safe and suitable for you. These will be discussed fully with you by the research team if you show interest in taking part.

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?
Have you recently had, or are you about to have, treatment for bowel (rectal) cancer?
Are you a man or a woman?
Are you interested in exploring ways to improve sexual function after cancer treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to either take Cialis tablets every day or to receive standard care. You won't know which group you're in, and neither will your doctors. You'll have regular check-ups and assessments over a period of 24 months (two years). These will involve answering questionnaires about your sexual function and general health, and regular physical examinations. You'll also have blood tests to check hormone levels. The study will track any side effects you experience. Your participation will involve multiple visits to the clinic over these two years, and the team will explain the schedule in detail.

Potential risks and benefits

Potential benefits of taking part include contributing to important research that could help future patients with bowel cancer. If you are in the Cialis group, the medication might help improve your sexual function. However, there's no guarantee of personal benefit, and Cialis can have side effects, which the medical team will explain thoroughly. You might also find the regular check-ups and discussions about sexual health beneficial. You are free to withdraw from the study at any time, for any reason, without it affecting your usual 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 is Cialis and why is it being used?

Cialis is a common medication, usually prescribed for erectile dysfunction in men. In this study, researchers are exploring if a low dose can also help improve sexual function in both men and women after bowel cancer treatment.

How long will I be involved in the study?

If you join, your involvement will last for 24 months, which is two years, with regular check-ups and assessments during that time.

Will I know if I'm taking Cialis or not?

No, this is a 'blinded' study. You will be randomly assigned to receive either Cialis or standard care, and neither you nor the study doctors will know which group you are in, to keep the results fair.

What kind of questionnaires will I need to fill out?

You'll be asked to complete questionnaires about your sexual function and general well-being. These are designed to understand how you are feeling and measure any changes over time.

Will my regular bowel cancer treatment be affected by this study?

No, participating in this study will not affect your standard treatment or care for your bowel cancer. The researchers are looking at ways to improve recovery alongside your existing care.