Title |
Vitamin D supplementation in cutaneous malignant melanoma outcome (ViDMe): a randomized controlled trial
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Published in |
BMC Cancer, August 2017
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DOI | 10.1186/s12885-017-3538-4 |
Pubmed ID | |
Authors |
J. De Smedt, S. Van Kelst, V. Boecxstaens, M. Stas, K. Bogaerts, D. Vanderschueren, C. Aura, K. Vandenberghe, D. Lambrechts, P. Wolter, O. Bechter, A. Nikkels, T. Strobbe, G. Emri, V. Marasigan, M. Garmyn |
Abstract |
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. 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. 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. Clinical Trial.gov, NCT01748448 , 05/12/2012. |
X Demographics
Geographical breakdown
Country | Count | As % |
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France | 1 | 50% |
Unknown | 1 | 50% |
Demographic breakdown
Type | Count | As % |
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Members of the public | 2 | 100% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
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Unknown | 159 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Student > Bachelor | 29 | 18% |
Student > Master | 20 | 13% |
Researcher | 14 | 9% |
Other | 11 | 7% |
Student > Postgraduate | 10 | 6% |
Other | 25 | 16% |
Unknown | 50 | 31% |
Readers by discipline | Count | As % |
---|---|---|
Medicine and Dentistry | 49 | 31% |
Nursing and Health Professions | 23 | 14% |
Biochemistry, Genetics and Molecular Biology | 7 | 4% |
Agricultural and Biological Sciences | 4 | 3% |
Pharmacology, Toxicology and Pharmaceutical Science | 4 | 3% |
Other | 16 | 10% |
Unknown | 56 | 35% |