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Anti-metabolites
Nicotinamide for Non-melanoma Skin Cancer (SPRINTR Trial)
Phase 3
Recruiting
Led By An-Wen Chan
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 208 weeks
Awards & highlights
SPRINTR Trial Summary
This trial will study if Vitamin B3 can reduce skin cancer risk in transplant recipients, to improve the long-term health of these patients.
Who is the study for?
This trial is for adult organ transplant recipients who are on specific immunosuppressants, have had a kidney, liver, heart, or lung transplant over two years ago and have previously had skin cancer. They must be able to attend follow-up visits but can't join if they've used certain vitamins recently, had other cancers or severe organ disease in the last five years, are pregnant or breastfeeding.Check my eligibility
What is being tested?
The study tests whether Nicotinamide (Vitamin B3) can prevent skin cancer in patients with organ transplants who are at high risk due to their anti-rejection medications. Participants will receive either Nicotinamide or placebo pills twice daily for up to four years across multiple Canadian centers.See study design
What are the potential side effects?
Potential side effects of Nicotinamide may include mild digestive upset such as nausea or vomiting, flushing of the skin due to dilation of blood vessels, dizziness and itching. However, individual reactions can vary.
SPRINTR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 208 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~208 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to first biopsy-confirmed keratinocyte carcinoma (basal cell carcinoma or invasive cutaneous squamous cell carcinoma)
Secondary outcome measures
Acute graft rejection (biopsy-confirmed)
Change from baseline in annual Basal and Squamous Cell Carcinoma Quality of Life (BaSQoL) score
Graft loss or retransplantation
+13 moreSide effects data
From 2022 Phase 2 trial • 46 Patients • NCT0306147425%
Diarrhoea
17%
Fall
17%
Urinary tract infection
8%
Vomiting
8%
Anxiety
8%
Back pain
8%
Laboratory test abnormal
8%
Constipation
4%
Head Injury
4%
Transaminases increased
4%
Neuropathy peripheral
4%
Dyspepsia
4%
Upper respiratory tract infection
4%
Arthralgia
4%
Headache
4%
Rash
4%
Fungal infection
4%
Penile ulceration
4%
Syncoper
4%
Foot fracture
4%
Osteoporosis
4%
Tooth abscess
4%
Agitation
4%
Weight decreased
4%
Blood testosterone decreased
4%
Hiatus hernia
4%
Urticaria
4%
Pleocytosis
4%
Actinic keratosis
4%
Viral upper respiratory tract infection
4%
Thrombocytopenia
4%
Hyperlipidaemia
4%
Laceration
4%
Limb injury
4%
Post lumbar puncture syndrome
4%
Miliaria
4%
Pneumonia
4%
Diabetes mellitus
4%
Myalgia
4%
Colitis ulcerative
4%
Infection
4%
Coccydynia
4%
Cognitive disorder
4%
Renal cyst
4%
Colorectal cancer
4%
Parkinson's disease
4%
Dehydration
4%
Tremor
4%
Cancer surgery
4%
Glomerular Ffiltration rate decreased
4%
Vitamin D deficiency
4%
Foot deformity
4%
Hypokalaemia
4%
Psoriasis
4%
Dizziness
4%
Dysgeusia
4%
Basal cell carcinoma
4%
Eructation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Nicotinamide
SPRINTR Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: NicotinamideExperimental Treatment1 Intervention
Intervention Drug : Nicotinamide
Group II: PlaceboPlacebo Group1 Intervention
Intervention: Placebo Oral Capsule
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?
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,345 Previous Clinical Trials
26,453,118 Total Patients Enrolled
University Health Network, TorontoOTHER
1,476 Previous Clinical Trials
484,784 Total Patients Enrolled
NOW FoodsOTHER
5 Previous Clinical Trials
295 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a serious cancer or skin cancer spread in the last 5 years.I had a transplant (kidney, liver, heart, or lung) over two years ago.I can go to all my follow-up appointments.I am 18 years old or older.I have skin cancer that hasn't been treated yet, but I can join after treatment.I had a biopsy confirming an acute rejection episode in the last 12 weeks.I need to keep taking carbamazepine or primidone.I am on immunosuppressants like cyclosporine or tacrolimus.I have had skin cancer confirmed by a biopsy before.My liver is not functioning properly, with high enzyme or bilirubin levels.I haven't taken nicotinamide or niacin (250 mg or more daily) in the last 12 weeks.I have severe kidney disease.
Research Study Groups:
This trial has the following groups:- Group 1: Nicotinamide
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Nicotinamide been accredited by the FDA?
"Owing to various studies and trials demonstrating its efficacy, Nicotinamide was rated 3 out of a possible score of 3 for safety."
Answered by AI
In what geographical areas has this experiment been made available?
"This clinical trial has enlisted 8 sites to participate, with notable locations such as the University of Alberta in Edmonton, Vancouver General Hospital in Vancouver and St. Paul's Hospital in Ottawa."
Answered by AI
Are any additional volunteers being sought for this experiment?
"Unfortunately, this clinical trial is no longer accepting participants as evidenced on the clinicaltrials.gov website. It was initially posted August 1st 2023 and last updated July 13th 2023. However, there are currently 2679 other trials enrolling patients at present time."
Answered by AI
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