RecruitingPHASE3INTERVENTIONAL

Nicotinamide Chemoprevention for Keratinocyte Carcinoma in Solid Organ Transplant Recipients - Pivotal Trial

People who have had organ transplants often need to take medicines to stop their body from rejecting the new organ. Over time, these medicines can increase their risk of developing skin cancer. This study is investigating whether a vitamin B3 supplement, called nicotinamide, can help prevent new skin cancers in these patients. It's especially focused on certain types of non-melanoma skin cancer. Researchers will give either nicotinamide or a dummy pill (placebo) to transplant patients who have already had at least one skin cancer. The study will look into how well nicotinamide works and if it's safe to use, in the hope of improving the long-term health of people who have received transplants.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Women's College Hospital

Enrolment target

396

Start

28 Aug 2023

Estimated completion

01 Aug 2027

Non-melanoma Skin Cancer Carcinoma, Squamous Cell Carcinoma, Basal Cell Keratinocyte Carcinoma

What is this study about?

When someone receives an organ transplant, they need to take special medicines for the rest of their lives to make sure their body doesn't reject the new organ. While these medicines are life-saving, they can also have some long-term side effects. One important side effect is an increased risk of skin cancer. This is because the medicines can weaken the body's immune system, which usually helps fight off abnormal cells that can turn into cancer. For people who have had transplants, skin cancer is quite common and can sometimes be more serious than in others.

This study is looking at an everyday vitamin B3 supplement called nicotinamide. Studies in the general population have suggested that nicotinamide might help prevent certain types of skin cancer. However, it's not yet clear if it works in the same way, or if it's safe, for people who have had organ transplants and are taking immune-suppressing medicines. That's why this research is so important.

The main goal of this study is to find out if taking nicotinamide regularly can reduce the number of new skin cancers in transplant patients who are already at high risk because they've had skin cancer before. Researchers will also be checking to see if nicotinamide is safe for these patients and if it has any impact on their quality of life. The findings from this study could help doctors better protect transplant patients from skin cancer in the future.

Key takeaways

Targets non-melanoma skin cancer in organ transplant recipients.
Investigates vitamin B3 (nicotinamide) to prevent new skin cancers.
Compares nicotinamide with a dummy pill (placebo).
Focuses on safety and effectiveness over up to four years.
Aims to improve long-term health for transplant patients.
Participants must have a history of skin cancer after transplant.

Who may be eligible?

This study is looking for adults aged 18 or over who have had a kidney, liver, heart, or lung transplant at least two years ago. You would need to have had at least one non-melanoma skin cancer in the past and currently be taking specific anti-rejection medicines. You also need to be able to attend all the necessary follow-up appointments.

There are some reasons why you wouldn't be able to join. For example, if you've recently had an organ rejection episode, have certain liver or very severe kidney problems, or have had other types of cancer in the last five years. You also can't be pregnant, breastfeeding, or taking high doses of similar vitamins already. If you have any untreated skin cancer, you'd need to have it treated before you could join.

Your study doctor will go through all these details with you carefully to make sure this study is the right fit for your health situation.

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 had a kidney, liver, heart, or lung transplant at least two years ago?
Have you had at least one non-melanoma skin cancer confirmed by a doctor?
Are you currently taking anti-rejection medicines that typically include cyclosporine or tacrolimus?
Are you able to attend regular follow-up appointments?
Are you NOT pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to either receive nicotinamide tablets or dummy tablets (placebo) for up to four years. Neither you nor your study doctor would know which tablets you are taking. You would need to take these tablets twice a day.

Over the course of the study, you would have regular follow-up visits. During these visits, the study team would check your health, ask about any changes or side effects, and monitor for any new skin cancers. These visits would also involve blood tests and other routine checks to make sure you are safe and the treatment is not causing any problems. The total duration of your participation could be up to four years.

Potential risks and benefits

Taking part in this study could potentially reduce your risk of developing new skin cancers, which could improve your long-term health and well-being. However, there's no guarantee that you will personally benefit. Nicotinamide is generally considered safe, but like all medicines or supplements, it can have side effects, which your doctor will discuss with you. There are also risks associated with study procedures like blood draws. If you decide to join, you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (7)

University of Calgary
Verified postcode
Calgary, Canada· Not yet recruiting
University of Alberta
Verified postcode
Edmonton, Canada· Recruiting
Vancouver General Hospital
Verified postcode
Vancouver, Canada· Recruiting
St. Paul's Hospital
Verified postcode
Vancouver, Canada· Recruiting
The Ottawa Hospital
Verified postcode
Ottawa, Canada· Recruiting
Toronto General Hospital
Verified postcode
Toronto, Canada· Recruiting
Women's College Hospital
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is nicotinamide?

Nicotinamide is a type of vitamin B3. It's often found in food and is sometimes used as a supplement.

What is a placebo?

A placebo is a 'dummy' tablet that looks just like the study drug but doesn't contain any active medicine. It helps researchers compare the effects of the active drug.

How long will the study last?

Your participation in the study could last for up to four years.

Will I still get my usual medical care for my transplant?

Yes, this study involves taking nicotinamide in addition to your standard medical care and anti-rejection medicines. Your usual care will continue as normal.

Can I stop taking part if I change my mind?

Yes, absolutely. You can withdraw from the study at any time without having to give a reason, and it won't affect your future medical care.

How to find out more

Stephanie Jewell, BSc. Hons

sprintr@wchospital.ca 416 351-3732 Official trial record

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