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)

Randomised double blinded placebo controlled trial to assess the effect of oral nicotinamide on numbers of new nonmelanoma skin cancers in immune competent adult patients with a history of at least two histologically confirmed nonmelanoma skin cancers within the previous five years

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000625875

Acronym

ONTRAC (Oral Nicotinamide To Reduce Actinic Cancer)

Enrollment

386

Registered

2012-06-12

Start date

2012-07-02

Completion date

2013-06-14

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to assess the effect of nicotinamide (vitamin B3) on incidence of nonmelanoma skin cancer and actinic keratoses. Who is it for? You may be eligible to join this study if you are aged 18 years or more and have had at least two confirmed nonmelanoma skin cancers within the previous 5 years. Trial details Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in one group will take two 500mg nicotinamide (vitamin B3) tablets daily for 12 months, whilst those in the other group will take two placebo (inactive) tablets daily instead. Participants will not know which group they are in until the end of the trial. Participants will be regularly assessed over the treatment period and for 6 months after the treatment period to determine the efficacy of nicotinamide in preventing nonmelanoma skin cancer.

Interventions

Oral nicotinamide 500mg orally twice daily for 12 months

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

Outcome results