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Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/24957

Title: Vitamin D supplementation in cutaneous malignant melanoma outcome (ViDMe): a randomized controlled trial
Authors: De Smedt, J.
Van Kelst, S.
Boecxstaens, V.
Stas, M.
Bogaerts, Kris
Vanderschueren, D.
Aura, C.
Vandenberghe, K.
Lambrechts, D.
Wolter, P.
Bechter, O.
Nikkels, A.
Strobbe, T.
Emri, G.
Marasigan, V.
Garmyn, M.
Issue Date: 2017
Citation: BMC CANCER, 17, p. 1-10 (Art N° 562)
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.
Notes: [De Smedt, J.; Van Kelst, S.; Garmyn, M.] Katholieke Univ Leuven, Dept Oncol, Lab Dermatol, B-3000 Louvain, Belgium. [De Smedt, J.; Van Kelst, S.; Garmyn, M.] Univ Hosp Leuven, Dept Dermatol, B-3000 Leuven, Belgium. [Boecxstaens, V.; Stas, M.] Univ Hosp Leuven, Dept Surg Oncol, Oncol & Vasc Access Surg, B-3000 Leuven, Belgium. [Boecxstaens, V.; Stas, M.] Katholieke Univ Leuven, Dept Oncol, B-3000 Leuven, Belgium. [Bogaerts, K.] Katholieke Univ Leuven, Fac Med, I BioStat, B-3000 Leuven, Belgium. [Bogaerts, K.] Hasselt Univ, I BioStat, B-3590 Diepenbeek, Belgium. [Vanderschueren, D.] Katholieke Univ Leuven, Dept Clin & Expt Med, Clin & Expt Endocrinol, B-3000 Leuven, Belgium. [Vanderschueren, D.] Univ Hosp Leuven, Dept Endocrinol, B-3000 Leuven, Belgium. [Aura, C.] Katholieke Univ Leuven, Dept Imaging & Pathol, Translat Cell & Tissue Res, B-3000 Leuven, Belgium. [Aura, C.] Univ Hosp Leuven, Dept Pathol, B-3000 Leuven, Belgium. [Vandenberghe, K.] Katholieke Univ Leuven, Dept Cardiovasc Sci, B-3000 Leuven, Belgium. [Lambrechts, D.; Marasigan, V.] Katholieke Univ Leuven, Dept Oncol, Lab Translat Genet, B-3000 Leuven, Belgium. [Lambrechts, D.] VIB, Res Ctr, B-3000 Leuven, Belgium. [Wolter, P.] CHR Verviers East Belgium, Dept Hematol & Oncol, B-4800 Verviers, Belgium. [Bechter, O.] Katholieke Univ Leuven, Dept Oncol, LEO, B-3000 Leuven, Belgium. [Bechter, O.] Univ Hosp Leuven, Leuven Canc Inst, Dept Gen Med Oncol, B-3000 Leuven, Belgium. [Nikkels, A.] Univ Liege, CHU Sart Tilman, Dept Dermatol, B-4000 Liege, Belgium. [Strobbe, T.] Univ Antwerp Hosp, Dept Dermatol, B-2650 Edegem, Belgium. [Emri, G.] Univ Debrecen, Fac Med, Dept Dermatol, H-4012 Debrecen, Hungary.
URI: http://hdl.handle.net/1942/24957
DOI: 10.1186/s12885-017-3538-4
ISI #: 000408849000004
ISSN: 1471-2407
Category: A1
Type: Journal Contribution
Validation: ecoom, 2018
Appears in Collections: Research publications

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