UnknownPhase 2

Skin Cancer Prevention With Nicotinamide in Transplant Recipients - Pilot Trial

Canada120 participantsStarted 2018-12-03

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

✕. Use of mTOR inhibitor (sirolimus, everolimus) within the past 12 weeks
✕. Biopsy-confirmed acute rejection episode within the past 12 weeks
✕. Active liver disease (elevated AST or ALT \>3 times normal)
✕. Severe renal failure (estimated glomerular filtration rate \<20 mL/min/1.73 m2)
✕. Current carbamazepine or primidone use
✕. Pregnancy and lactation
✕. Gorlin syndrome or other genetic skin cancer syndrome
✕. 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

What they're measuring

Feasibility (pertaining to patient recruitment)

Timeframe: 1 year

Feasibility (pertaining to appropriateness of eligibility criteria)

Timeframe: 1 year

Feasibility (pertaining to adherence to intervention)

Timeframe: 1 year

Feasibility (pertaining to adherence to follow-up assessments)

Timeframe: 1 year

Feasibility (pertaining to data linkage)

Timeframe: 1 year

Preliminary pooled keratinocyte carcinoma event rate

Timeframe: 1 year

Drug interactions

Timeframe: 1 week

Drug interactions

Timeframe: 2 weeks

Serious adverse events

Trial details

NCT IDNCT03769285

SponsorWomen's College Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12

View on ClinicalTrials.gov More Non-melanoma Skin Cancer trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

✕. Use of mTOR inhibitor (sirolimus, everolimus) within the past 12 weeks
✕. Biopsy-confirmed acute rejection episode within the past 12 weeks
✕. Active liver disease (elevated AST or ALT \>3 times normal)
✕. Severe renal failure (estimated glomerular filtration rate \<20 mL/min/1.73 m2)
✕. Current carbamazepine or primidone use
✕. Pregnancy and lactation
✕. Gorlin syndrome or other genetic skin cancer syndrome
✕. 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

What they're measuring

Feasibility (pertaining to patient recruitment)

Timeframe: 1 year

Feasibility (pertaining to appropriateness of eligibility criteria)

Timeframe: 1 year

Feasibility (pertaining to adherence to intervention)

Timeframe: 1 year

Feasibility (pertaining to adherence to follow-up assessments)

Timeframe: 1 year

Feasibility (pertaining to data linkage)

Timeframe: 1 year

Preliminary pooled keratinocyte carcinoma event rate

Timeframe: 1 year

Drug interactions

Timeframe: 1 week

Drug interactions

Timeframe: 2 weeks

Serious adverse events