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Skin Cancer Prevention With Nicotinamide in Transplant Recipients - Pilot Trial

NCT03769285 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-04-06

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Nicotinamide

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

DRUG

Placebo oral capsule

Matching placebo taken twice daily for at least 52 weeks

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • The Kidney Foundation of Canada

    collaborator OTHER

  • NOW Foods

    collaborator OTHER

  • Natural Life Nutrition

    collaborator UNKNOWN

  • Women's College Hospital

    lead OTHER

Principal Investigators

  • An-Wen Chan, MD DPhil · Women's College Hospital

  • Joseph Kim, MD PhD · University Health Network, Toronto

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-03
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03769285 on ClinicalTrials.gov