Vitamin D Supplementation in Cutaneous Malignant Melanoma Outcome (ViDMe): A Randomized Controlled Trial

BMC Cancer. 2017 Aug 23;17(1):562. doi: 10.1186/s12885-017-3538-4.

Abstract

Background: Previous studies have investigated the protective effect of vitamin D serum levels, at diagnosis and during the follow-up period after treatment, on melanoma outcome. In the present study we assess whether vitamin D supplementation, in the follow-up period after diagnosis and surgical resection of the primary tumor, has a protective effect on relapse of cutaneous malignant melanoma and whether this protective effect correlates with vitamin D levels in serum and Vitamin D Receptor immunoreactivity in the primary tumor.

Methods/design: This study is a multicenter randomized double blind placebo- controlled phase III trial. Patients between the age of 18 and 80 years diagnosed and treated surgically for a melanoma stage IB-III are eligible for randomization in a 1:1 ratio to active treatment or placebo. The study drug is taken each month and consists of either 100,000 International Unit cholecalciferol or arachidis oleum raffinatum used as a placebo. The primary endpoint is relapse free survival. The secondary endpoints are 25 hydroxyvitamin D3 serum levels at diagnosis and at 6 month intervals, melanoma subtype, melanoma site and stage of melanoma at diagnosis according to the 2009 American Joint Committee on Cancer melanoma staging and classification. At randomization a bloodsample is taken for DNA analysis. The study is approved by the local Ethics Committees.

Discussion: If we can confirm our hypothesis that vitamin D supplementation after removal of the tumor has a protective effect on relapse of cutaneous malignant melanoma we may reduce the burden of CMM at several levels. Patients, diagnosed with melanoma may have a better clinical outcome and improved quality of life. There will be a decrease in health care costs related to treatment of metastatic disease and there will be a decrease in loss of professional years, which will markedly reduce the economic burden of the disease.

Trial registration: Clinical Trial.gov, NCT01748448 , 05/12/2012.

Keywords: Melanoma; Randomized controlled trial; Safety; Secondary prevention; Vitamin D.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Belgium / epidemiology
  • Calcifediol / blood
  • Clinical Protocols*
  • Dietary Supplements*
  • Disease Progression
  • Female
  • Health Knowledge, Attitudes, Practice
  • Humans
  • Male
  • Melanoma / epidemiology*
  • Melanoma / etiology
  • Melanoma / mortality
  • Melanoma / pathology
  • Middle Aged
  • Neoplasm Staging
  • Patient Outcome Assessment
  • Receptors, Calcitriol / genetics
  • Receptors, Calcitriol / metabolism
  • Risk Factors
  • Skin Neoplasms / epidemiology*
  • Skin Neoplasms / etiology
  • Skin Neoplasms / mortality
  • Skin Neoplasms / pathology
  • Vitamin D* / administration & dosage
  • Vitamin D* / adverse effects
  • Young Adult

Substances

  • Receptors, Calcitriol
  • Vitamin D
  • Calcifediol

Supplementary concepts

  • Melanoma, Cutaneous Malignant

Associated data

  • ClinicalTrials.gov/NCT01748448