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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
Pivotal 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.
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.
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~208 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 208 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Acute graft rejection (biopsy-confirmed)
Graft loss or retransplantation
High/low cyclosporine or tacrolimus blood concentration requiring dose adjustment
+2 more

Side effects data

From 2022 Phase 2 trial • 46 Patients • NCT03061474
25%
Diarrhoea
17%
Urinary tract infection
17%
Fall
8%
Constipation
8%
Vomiting
8%
Anxiety
8%
Laboratory test abnormal
8%
Back pain
4%
Upper respiratory tract infection
4%
Cognitive disorder
4%
Coccydynia
4%
Agitation
4%
Fungal infection
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%
Foot deformity
4%
Osteoporosis
4%
Headache
4%
Eructation
4%
Pleocytosis
4%
Limb injury
4%
Renal cyst
4%
Laceration
4%
Myalgia
4%
Hyperlipidaemia
4%
Dizziness
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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
1,388 Previous Clinical Trials
26,517,677 Total Patients Enrolled
University Health Network, TorontoOTHER
1,523 Previous Clinical Trials
502,942 Total Patients Enrolled
Women's College HospitalLead Sponsor
106 Previous Clinical Trials
43,165 Total Patients Enrolled

Media Library

Nicotinamide (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT05955924 — Phase 3
Basal Cell Carcinoma Research Study Groups: Nicotinamide, Placebo
Basal Cell Carcinoma Clinical Trial 2023: Nicotinamide Highlights & Side Effects. Trial Name: NCT05955924 — Phase 3
Nicotinamide (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05955924 — Phase 3
~264 spots leftby Aug 2027
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