Vitamin D supplementation in cutaneous malignant melanoma outcome (ViDMe): a randomized controlled trial

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.

Vitamin D supplementation and clinical outcomes in cancer survivorship

“…Several RCTs are also currently ongoing and will extend current knowledge by investigating the protective effects of VD supplementation on other cancers, including melanoma (Saw et al, 2014;De Smedt et al, 2017).…”

Current Molecular Markers of Melanoma and Treatment Targets

“…A phase 2 trial (Mel-D) is underway in Australia to assess the safety and progression-free survival results of high dose vitamin D therapy in patients who have had surgical excision of melanoma and are at high risk for recurrence [55]. In a Belgian phase 3 trial (ViDMe), relapse-free survival is being assessed in patients treated with cholecalciferol after primary excision of melanoma [56]. The results of these trials will provide key understanding for the therapeutic utility of vitamin D in combination with the assessment of VDR expression.…”

The Role of the Vitamin D Receptor in the Pathogenesis, Prognosis, and Treatment of Cutaneous Melanoma

“…The ongoing study, VidMe, is a multicenter randomized placebo-controlled phase III trial intended to examine the efficacy and long-term safety of high-dose vitamin D supplementation in 500 patients with melanoma (ClinicalTrials.gov Identifier: NCT01748448) (110,111). Once a month, participants will either receive 100,000 IU of vitamin D or placebo (Arachidis oleum raffinatum).…”