Skin Cancer Prevention With Nicotinamide in Transplant Recipients - Pilot Trial

• Status: Unknown status
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

A common long-term side effect of anti-rejection (immunosuppressant) medications is skin cancer. This pilot clinical trial evaluates the feasibility of conducting a larger pivotal trial to examine the efficacy and safety of nicotinamide for prevention of keratinocyte carcinoma in solid organ transplant recipients. This pilot trial will transition into the pivotal trial if all feasibility targets are met.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Women's College Hospital
• Collaborators: Canadian Institutes of Health Research (CIHR); Natural Life Nutrition; NOW Foods; The Kidney Foundation of Canada
• Treatments: Niacin; Niacinamide; Nicotinic Acids

Criteria

Inclusion Criteria:

1. Age ≥ 18 years old

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

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

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

5. Able to attend follow-up visits

6. Able to speak and understand English (only for cognitive substudy)

Exclusion Criteria:

1. Use of mTOR inhibitor (sirolimus, everolimus) within the past 12 weeks

2. Biopsy-confirmed acute rejection episode within the past 12 weeks

3. Active liver disease (elevated AST or ALT >3 times normal)

4. Severe renal failure (estimated glomerular filtration rate <20 mL/min/1.73 m2)

5. Current carbamazepine or primidone use

6. Pregnancy and lactation

7. Gorlin syndrome or other genetic skin cancer syndrome

8. Solid organ or hematologic malignancy, invasive Stage II melanoma, Merkel cell carcinoma, or metastatic skin cancer within the past five years, or invasive Stage I melanoma within the past two years

9. Untreated localized skin cancer (invasive squamous cell carcinoma, basal cell carcinoma, or keratoacanthoma) at baseline (the patient can enrol after skin cancer treatment)

10. Use of nicotinamide or niacin within the past 12 weeks

11. Use of field therapy for actinic keratoses within the past 12 weeks

12. Initiation of systemic chemoprevention within the past 12 weeks