Skin Cancer Prevention With Nicotinamide in Transplant Recipients - Pilot Trial

Nicotinamide Chemoprevention for Keratinocyte Carcinoma in Solid Organ Transplant Recipients: A Pilot, Placebo-controlled, Randomized Trial

Sponsors

Lead Sponsor: Women's College Hospital

Collaborator: Canadian Institutes of Health Research (CIHR)
The Kidney Foundation of Canada
NOW Foods
Natural Life Nutrition

Source Women's College Hospital
Brief 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.

Overall Status Recruiting
Start Date December 3, 2018
Completion Date December 2020
Primary Completion Date December 2020
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Feasibility (pertaining to patient recruitment) 1 year
Feasibility (pertaining to appropriateness of eligibility criteria) 1 year
Feasibility (pertaining to adherence to intervention) 1 year
Feasibility (pertaining to adherence to follow-up assessments) 1 year
Feasibility (pertaining to data linkage) 1 year
Preliminary pooled keratinocyte carcinoma event rate 1 year
Drug interactions 1 week
Drug interactions 2 weeks
Serious adverse events 1 year
Secondary Outcome
Measure Time Frame
Feasibility of recruiting for neurocognitive substudy 1 year
Baseline prevalence of cognitive impairment (substudy) 1 year
Pooled standard deviation of MoCA test scores (substudy) 1 year
Pooled standard deviation of Hopkins Verbal Learning Test - Revised scores (substudy) 1 year
Pooled standard deviation of Trail Making A and B test scores (substudy) 1 year
Pooled standard deviation of Controlled Oral Word Association test scores (substudy) 1 year
Pooled standard deviation of Animal Naming Task scores (substudy) 1 year
Pooled standard deviation of cognitive test scores (substudy) 1 year
Pooled standard deviation of serum phosphate levels (substudy) 1 year
Enrollment 120
Condition
Intervention

Intervention Type: Drug

Intervention Name: Nicotinamide

Description: Oral nicotinamide (500 mg) twice daily for at least 52 weeks

Arm Group Label: Nicotinamide

Other Name: niacinamide

Intervention Type: Drug

Intervention Name: Placebo oral capsule

Description: Matching placebo taken twice daily for at least 52 weeks

Arm Group Label: Placebo

Eligibility

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Overall Contact

Last Name: Ashley Lau, BMRSc

Phone: 416-351-3732

Phone Ext.: 2706

Email: [email protected]

Location
Facility: Status: Contact: Toronto General Hospital, University Health Network Ashley Lau, BMRSc 416-351-3732 2706 [email protected]
Location Countries

Canada

Verification Date

June 2019

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Nicotinamide

Type: Experimental

Label: Placebo

Type: Placebo Comparator

Acronym SPRINTR-Pilot
Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov