ONTRAC: Effect of oral nicotinamide (vitamin B3) on incidence of nonmelanoma skin cancer and actinic keratoses: a randomised controlled trial (Oral Nicotinamide To Reduce Actinic Cancer)

Phase 3

Completed

• Conditions: onmelanoma skin cancer; Actinic keratoses; Basal cell carcinoma; Cutaneous squamous cell carcinoma; Cognitive function; Transepidermal water loss; Nonmelanoma skin cancer; Cancer - Non melanoma skin cancer; Neurological - Studies of the normal brain and nervous system; Skin - Other skin conditions

• Registration Number: ACTRN12612000625875
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-06-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 386

Inclusion Criteria

Aged 18 years or older with at least two histologically confirmed nonmelanoma skin cancers with the previous 5 years
Equivalent to Year 8 spoken and written English skills to participate in the cognitive component of the study.

Exclusion Criteria

1.Immune suppression (due to current immune suppressive medication, or immune suppressive medical condition such as haematological malignancy, HIV infection, congenital immune deficiency)
2.Severe liver disease (transaminases >3x normal)
3.Active peptic ulcer disease
4.Recent myocardial infarction
5.Hypotension
6.Renal impairment with eGFR < 30 mL/min/1.73 m2
7.Internal malignancy, metastatic SCC or invasive melanoma within the past 5 years.
8.Need for ongoing carbamazepine use (possible interaction with nicotinamide).
9.Patients unavailable for follow up for the duration of the study because of general frailty, geographical or social reasons.
10.Gorlin’s syndrome or other genetic skin cancer syndrome.
11.Huge numbers of current skin cancers or large areas of confluent skin cancer at baseline preventing accurate assessment and counting of new skin cancers.
12.Pregnancy or lactation (any women of childbearing potential will be required to use contraception throughout the study).
13.Patients taking acitretin or other oral retinoids within the past 6 months
14.Taking supplemental nicotinamide or niacin (other nicotinamide supplements to be ceased 4 weeks prior to study commencement).
15.Field treatment for AKs (topical use of 5 fluorouracil, imiquimod, diclofenac, retinoids; topical photodynamic therapy for AKs; laser resurfacing or chemical peel treatments for AKs) within the previous 4 weeks.

Study & Design

• Study Type: Interventional
• Study Design: Not specified