Interest of Early Erectile Rehabilitation With Sildenafil After Radiotherapy and Proctectomy for Rectal Cancer
This research is investigating if a common medication for erection problems, Sildenafil (known commercially as Viagra), can help men recover their sexual function sooner after treatment for bowel cancer. When men have surgery and radiotherapy for bowel cancer, it can sometimes lead to difficulties getting or keeping an erection. This study aims to see if starting Sildenafil early can prevent these problems from lasting a long time. Researchers will compare Sildenafil with a placebo, which is a tablet that looks the same but contains no active medicine, to understand its effects better. The main goal is to find out if Sildenafil can help prevent long-term erection problems 12 months after surgery.
At a glance
What is this study about?
Bowel cancer is quite common in men. One of the main ways to treat it is with surgery, sometimes alongside radiotherapy (X-ray treatment). While these treatments are very effective at fighting the cancer, they can sometimes cause unwanted side effects, such as problems with erections. This can be very upsetting for men and can affect their quality of life.
Erection problems after bowel cancer treatment can happen for a few reasons. Surgery, even when surgeons are very careful, can sometimes affect the delicate nerves that control erections. Radiotherapy can also damage the blood vessels that are important for erections. These issues can lead to changes in the penis tissue over time, making it harder to achieve and maintain an erection.
This study is exploring whether starting Sildenafil early, shortly after treatment, can help reduce these long-term erection problems. Sildenafil works by increasing blood flow to the penis when a man is sexually aroused. By using it early, researchers hope it might help keep the tissues healthy and prevent permanent changes that lead to ongoing erection difficulties.
Key takeaways
- This study evaluates Sildenafil (Viagra) for erection problems.
- It's for men treated for bowel cancer with surgery and radiotherapy.
- The goal is to prevent long-term erection difficulties.
- You might receive Sildenafil or a dummy pill (placebo).
- Participation involves taking medication and attending follow-up visits.
Who may be eligible?
To join this study, we are looking for men between 18 and 70 years old who are having surgery for bowel cancer that involves removing part of their rectum, after they've had radiotherapy. You must have had normal erections before your surgery, be sexually active, and have a regular sexual partner. The surgery you've had must be one where the surgeon tried to protect the nerves around the rectum.
There are also some reasons why you might not be able to join. For example, if your tumour is very large, or if you had erection problems before your surgery. If you have had prostate cancer, or if you take certain medicines like sedatives or sleeping pills, you also wouldn't be able to take part. There are medical conditions and certain medicines that mean Sildenafil isn't safe for you, so we would check for those too. Finally, if you're already in another drug trial, or if you couldn't fully understand what the study involves, you wouldn't be eligible.
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 man aged between 18 and 70?
- Did you have normal erections before your bowel cancer surgery?
- Are you sexually active and have a regular partner?
- Did your surgeon try to protect the nerves during your bowel cancer operation?
- Do you not have medical reasons that make Sildenafil unsafe for you?
What does participation involve?
If you decide to take part, you would be randomly assigned to take either Sildenafil or a dummy pill (placebo) for a period after your surgery. You would need to attend regular follow-up appointments where your sexual function and general health would be assessed. This usually involves answering questionnaires. The total duration of your participation, including follow-up, would be confirmed by the study team, but the main assessment of erection problems is at 12 months after your surgery. All details about the specific tablets and the schedule of visits will be explained thoroughly by the study staff.
Potential risks and benefits
Locations (14)
- Chu AmiensVerified postcodeAmiens, France· Recruiting
- Hopital BeauvaisVerified postcodeBeauvais, France· Recruiting
- Chu BesanconVerified postcodeBesançon, France· Recruiting
- Aphp BicetreVerified postcodeBicêtre, France· Recruiting
- Chu BordeauxVerified postcodeBordeaux, France· Recruiting
- Institut Bordeaux ColorectalVerified postcodeBordeaux, France· Recruiting
- Chu Clermont-FerrandVerified postcodeClermont-Ferrand, France· Recruiting
- Chu LilleVerified postcodeLille, France· Recruiting
- Institut Paoli-CalmettesVerified postcodeMarseille, France· Recruiting
- Institut Du Cancer MontpellierVerified postcodeMontpellier, France· Recruiting
- Aphp St AntoineVerified postcodeParis, France· Recruiting
- Aphp HegpVerified postcodeParis, France· Recruiting
Common questions
What is Sildenafil?
Sildenafil is a common medicine, often known as Viagra, used to help men get and keep an erection.
What is a placebo?
A placebo is a 'dummy' pill that looks just like the study medicine but contains no active ingredients. It helps us see if the medicine really works.
Will I know if I'm taking Sildenafil or the placebo?
No, this is a 'blinded' study, meaning neither you nor your doctor will know which treatment you are receiving until the study is over.
Why is this study needed?
It's to find out if early use of Sildenafil can prevent long-term erection difficulties that can happen after bowel cancer treatment.
Does this study involve new, untested drugs?
No, Sildenafil is a well-known and approved medication. This study is testing if using it early for this specific purpose is beneficial.
How to find out more
Valérie Bridoux
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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