Nicotinamide Chemoprevention for Keratinocyte Carcinoma in Solid Organ Transplant Recipients: a Multicentre, Pragmatic Randomized Trial

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

As patients live longer after receiving an organ transplant, there is a need to reduce the long-term side effects of the drugs used to prevent organ rejection. In particular, long-term use of these drugs increases the risk of skin cancer. Skin cancer is now a leading cause of illness and disfigurement after kidney, liver, heart, and lung transplantation. Given the increased risk and burden of skin cancer in transplant recipients, prevention is critical. Nicotinamide is a form of Vitamin B3 that has been shown to protect against skin cancer in the general population. However, it is unclear whether nicotinamide is effective among immune-suppressed transplant recipients. Investigators will conduct a clinical trial involving multiple transplant centres in Canada to evaluate whether oral nicotinamide (500 mg twice daily) is effective and safe for preventing skin cancer. Investigators will recruit 396 high-risk adult kidney, liver, heart, and lung transplant patients who have previously had at least one skin cancer. Patients will receive nicotinamide or sham tablets for up to 4 years. The results will inform efforts to improve the long-term health of transplant recipients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years old

• Kidney, liver, heart, or lung transplant at least two years ago

• History of at least one prior histologically-confirmed keratinocyte carcinoma or squamous cell carcinoma in situ

• Currently immunosuppressed with a calcineurin inhibitor-based regimen (cyclosporine or tacrolimus)

• Able to attend follow-up visits

Locations
Other Locations
Canada
University of Calgary
NOT_YET_RECRUITING
Calgary
University of Alberta
RECRUITING
Edmonton
The Ottawa Hospital
RECRUITING
Ottawa
Toronto General Hospital
RECRUITING
Toronto
Women's College Hospital
RECRUITING
Toronto
St. Paul's Hospital
RECRUITING
Vancouver
Vancouver General Hospital
RECRUITING
Vancouver
Contact Information
Primary
Stephanie Jewell, BSc. Hons
sprintr@wchospital.ca
416 351-3732
Time Frame
Start Date: 2023-08-28
Estimated Completion Date: 2027-08
Participants
Target number of participants: 396
Treatments
Experimental: Nicotinamide
Intervention Drug : Nicotinamide
Placebo_comparator: Placebo
Intervention: Placebo Oral Capsule
Related Therapeutic Areas
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR), University Health Network, Toronto, NOW Foods
Leads: Women's College Hospital

This content was sourced from clinicaltrials.gov