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Vitamin B3 Analog
Nicotinamide for Skin Cancer Prevention (SPRINTR-Pilot Trial)
Phase 2
Waitlist Available
Led By An-Wen Chan, MD DPhil
Research Sponsored by Women's College Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Summary
This trial will test if a drug called nicotinamide can help prevent skin cancer in people who have had organ transplants. If it is successful, it will become a larger trial.
Eligible Conditions
- Head and Neck Cancers
- Basal Cell Carcinoma
- Skin Cancer
- Squamous Cell Carcinoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Drug interactions
Feasibility (pertaining to adherence to follow-up assessments)
Feasibility (pertaining to adherence to intervention)
+5 moreSecondary study objectives
Baseline prevalence of cognitive impairment (substudy)
Feasibility of recruiting for neurocognitive substudy
Pooled standard deviation of Animal Naming Task scores (substudy)
+5 moreSide effects data
From 2022 Phase 2 trial • 46 Patients • NCT0306147425%
Diarrhoea
17%
Urinary tract infection
17%
Fall
8%
Constipation
8%
Vomiting
8%
Anxiety
8%
Laboratory test abnormal
8%
Back pain
4%
Cognitive disorder
4%
Upper respiratory tract infection
4%
Coccydynia
4%
Agitation
4%
Fungal infection
4%
Dizziness
4%
Dysgeusia
4%
Syncoper
4%
Vitamin D deficiency
4%
Glomerular Ffiltration rate decreased
4%
Hypokalaemia
4%
Basal cell carcinoma
4%
Pneumonia
4%
Tremor
4%
Blood testosterone decreased
4%
Weight decreased
4%
Hyperlipidaemia
4%
Foot deformity
4%
Osteoporosis
4%
Headache
4%
Eructation
4%
Pleocytosis
4%
Limb injury
4%
Renal cyst
4%
Laceration
4%
Myalgia
4%
Diabetes mellitus
4%
Arthralgia
4%
Thrombocytopenia
4%
Dyspepsia
4%
Infection
4%
Post lumbar puncture syndrome
4%
Neuropathy peripheral
4%
Colorectal cancer
4%
Tooth abscess
4%
Colitis ulcerative
4%
Hiatus hernia
4%
Dehydration
4%
Parkinson's disease
4%
Transaminases increased
4%
Viral upper respiratory tract infection
4%
Foot fracture
4%
Head Injury
4%
Actinic keratosis
4%
Miliaria
4%
Penile ulceration
4%
Psoriasis
4%
Rash
4%
Urticaria
4%
Cancer surgery
100%
80%
60%
40%
20%
0%
Study treatment Arm
Nicotinamide
Placebo
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: NicotinamideExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotinamide
2021
Completed Phase 3
~2810
Find a Location
Who is running the clinical trial?
NOW FoodsOTHER
5 Previous Clinical Trials
571 Total Patients Enrolled
The Kidney Foundation of CanadaOTHER
15 Previous Clinical Trials
3,193 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,388 Previous Clinical Trials
26,517,953 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have used nicotinamide or niacin (at least 250 mg daily) in the last 12 weeks.You have used any treatment for actinic keratoses on your skin in the last 12 weeks.You have a genetic condition that increases your risk of developing skin cancer.You have had a type of cancer in your organs or blood, or certain types of skin cancer, within the past few years.You are currently taking carbamazepine or primidone medication.
Research Study Groups:
This trial has the following groups:- Group 1: Nicotinamide
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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