Prevention of Skin Cancer with nicotinamide in Transplant recipients

Nicotinamide as chemoprevention of Skin Cancer in Transplant recipietns

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

REBEC

Registry ID

RBR-8ht6j7q

Enrollment

Unknown

Registered

2021-03-16

Start date

2021-05-10

Completion date

Unknown

Last updated

2025-10-27

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

Conditions

Skin Neoplasms, transplant recipients, chemoprevention, Skin and Connective Tissue Diseases, Squamous Cell carcinoma, basal cell carcinoma, niacinamide

Interventions

156 patients will be recruited, 78 will receive nicotinamide medication (vitamin B3) and 78 will receive placebo for three months of use - 500 mg for 12/12 hours, totaling 180 capsules. They will be e

D009536

M01925

C04588805

Eligibility

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients older than 18 years; transplanted at least one year ago; with diagnosis of at least two NMSC in the last 12 months; who accept to participate in the study and agree to take the medication or placebo, by signing an Informed Consent Form.

Exclusion criteria

Exclusion criteria: Patients who do not wish to participate in the study; patients with impaired renal; hepatic or clotting function; patients who had malignant internal organ tumors in the last 5 years or malignant tumor metastases; pregnant or lactating women; patients on hemodialysis or peritoneal dialysis; patients who underwent treatment for actinic keratoses in the last 4 weeks; patients using systemic retinoids or with previous use of nicotinamide in the last 4 weeks

Design outcomes

Primary

Measure	Time frame
To evaluate the incidence of non-melanoma skin cancer detected by clinical examination and confirmed by histological examination in transplant patients who used nicotinamide medication compared to placebo.	—

Secondary

Measure	Time frame
To evaluate the incidence of actinic keratoses through clinical consultation between intervention and control groups;Evaluate remission or cure of actinic keratoses through clinical consultation between the intervention group and the placebo group;Assess the safety and tolerability of nicotineimide use in transplant patients through clinical consultation and laboratory tests every 3 months	—

Countries

Brazil

Contacts

Public ContactSabrina Sanvido

bita@hotmail.com+5551991224022

Outcome results

None listed

Source: REBEC (via WHO ICTRP)