Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Skin Cancer Prevention With Nicotinamide in Transplant Recipients - Pilot Trial (SPRINTR-Pilot)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03769285
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : June 24, 2019
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
The Kidney Foundation of Canada
NOW Foods
Natural Life Nutrition
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Non-melanoma Skin Cancer Carcinoma, Squamous Cell Carcinoma, Basal Cell Drug: Nicotinamide Drug: Placebo oral capsule Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Nicotinamide Chemoprevention for Keratinocyte Carcinoma in Solid Organ Transplant Recipients: A Pilot, Placebo-controlled, Randomized Trial
Actual Study Start Date : December 3, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nicotinamide Drug: Nicotinamide
Oral nicotinamide (500 mg) twice daily for at least 52 weeks
Other Name: niacinamide

Placebo Comparator: Placebo Drug: Placebo oral capsule
Matching placebo taken twice daily for at least 52 weeks




Primary Outcome Measures :
  1. Feasibility (pertaining to patient recruitment) [ Time Frame: 1 year ]
    Proportion of patients who consent to data linkage to provincial administrative databases

  2. Feasibility (pertaining to appropriateness of eligibility criteria) [ Time Frame: 1 year ]
    Reasons for exclusion of screened patients

  3. Feasibility (pertaining to adherence to intervention) [ Time Frame: 1 year ]
    Proportion of capsules returned, reasons for non-adherence

  4. Feasibility (pertaining to adherence to follow-up assessments) [ Time Frame: 1 year ]
    Proportion of missed assessments and incomplete questionnaire data variables, proportion of patients who withdraw from the trial, patient perception of trial participation

  5. Feasibility (pertaining to data linkage) [ Time Frame: 1 year ]
    Proportion of patients who consent to data linkage to provincial administrative databases

  6. Preliminary pooled keratinocyte carcinoma event rate [ Time Frame: 1 year ]
    Pooled keratinocyte carcinoma event rate to be used for sample size re-estimation in the pivotal trial.

  7. Drug interactions [ Time Frame: 1 week ]
    Proportion of patients with a clinically relevant increase in cyclosporine or tacrolimus blood concentration at 1 week. An increased level will be classified as clinically relevant if the transplant physician reduces the immunosuppressant dose in response to the increased drug level.

  8. Drug interactions [ Time Frame: 2 weeks ]
    Proportion of patients with a clinically relevant increase in cyclosporine or tacrolimus blood concentration at 2 weeks. This measurement will be dropped if all cases of clinically relevant drug interactions manifest at 1 week in the first 20 enrolled participants.

  9. Serious adverse events [ Time Frame: 1 year ]
    Descriptive tabulation (preliminary safety)


Secondary Outcome Measures :
  1. Feasibility of recruiting for neurocognitive substudy [ Time Frame: 1 year ]
    Proportion of enrolled participants who consent to participate in the neurocognitive substudy

  2. Baseline prevalence of cognitive impairment (substudy) [ Time Frame: 1 year ]
    Montreal Cognitive Assessment (MoCA) score <26, scored out of 30.

  3. Pooled standard deviation of MoCA test scores (substudy) [ Time Frame: 1 year ]
    Montreal Cognitive Assessment (MoCA), raw scores are scored out of 30, with a higher score representing better cognitive function

  4. Pooled standard deviation of Hopkins Verbal Learning Test - Revised scores (substudy) [ Time Frame: 1 year ]
    Hopkins Verbal Learning Test - Revised, a memory test scored out of 60, with a higher score representing better memory

  5. Pooled standard deviation of Trail Making A and B test scores (substudy) [ Time Frame: 1 year ]
    Trail Making A and B, a visual attention test. This records the time (in seconds) to completion, with a faster time representing better cognitive function

  6. Pooled standard deviation of Controlled Oral Word Association test scores (substudy) [ Time Frame: 1 year ]
    Controlled Oral Word Association, a verbal fluency test, measures the production of words belonging to the same letter. This records total number of words produced, with a higher number representing better verbal fluency.

  7. Pooled standard deviation of Animal Naming Task scores (substudy) [ Time Frame: 1 year ]
    Animal Naming Task, a verbal fluency task, measures the total number of animals named in one minute, with a higher number representing better verbal fluency

  8. Pooled standard deviation of cognitive test scores (substudy) [ Time Frame: 1 year ]
    Wechsler Adult Intelligence Scale - Revised, Digit Span subtest, a number sequencing memory test, measures the number of correctly repeated sequences with maximum score of 48. The higher score represents better cognitive function

  9. Pooled standard deviation of serum phosphate levels (substudy) [ Time Frame: 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03769285


Contacts
Layout table for location contacts
Contact: Ashley Lau, BMRSc 416-351-3732 ext 2706 ashley.lau@wchospital.ca

Locations
Layout table for location information
Canada, Ontario
Toronto General Hospital, University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2N2
Contact: Ashley Lau, BMRSc    416-351-3732 ext 2706    ashley.lau@wchospital.ca   
Sponsors and Collaborators
Women's College Hospital
Canadian Institutes of Health Research (CIHR)
The Kidney Foundation of Canada
NOW Foods
Natural Life Nutrition
Investigators
Layout table for investigator information
Principal Investigator: An-Wen Chan, MD DPhil Women's College Hospital
Principal Investigator: Joseph Kim, MD PhD University Health Network, Toronto

Layout table for additonal information
Responsible Party: Women's College Hospital
ClinicalTrials.gov Identifier: NCT03769285     History of Changes
Other Study ID Numbers: SPRINTR-Pilot
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: If feasibility thresholds are met, this pilot trial will proceed to a larger pivotal trial. The study protocol for the pivotal trial will be published prior to completion of data collection. Beyond 2 years after completion of the pivotal trial, the cleaned, anonymized, participant-level dataset and statistical code will made available for sharing with external researchers upon approval of a study proposal describing the intended data usage.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
Time Frame: 2 years after completion of the pivotal trial that follows this pilot trial

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Skin Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Neoplasms, Squamous Cell
Neoplasms, Basal Cell
Carcinoma
Carcinoma, Squamous Cell
Carcinoma, Basal Cell
Skin Diseases
Niacinamide
Niacin
Nicotinic Acids
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents