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Vitamin D supplementation in cutaneous malignant melanoma outcome (ViDMe): a randomized controlled trial
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 re...
Autores principales: | , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2017
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5569491/ https://www.ncbi.nlm.nih.gov/pubmed/28835228 http://dx.doi.org/10.1186/s12885-017-3538-4 |
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author | De Smedt, J. Van Kelst, S. Boecxstaens, V. Stas, M. Bogaerts, K. Vanderschueren, D. Aura, C. Vandenberghe, K. Lambrechts, D. Wolter, P. Bechter, O. Nikkels, A. Strobbe, T. Emri, G. Marasigan, V. Garmyn, M. |
author_facet | De Smedt, J. Van Kelst, S. Boecxstaens, V. Stas, M. Bogaerts, K. Vanderschueren, D. Aura, C. Vandenberghe, K. Lambrechts, D. Wolter, P. Bechter, O. Nikkels, A. Strobbe, T. Emri, G. Marasigan, V. Garmyn, M. |
author_sort | De Smedt, J. |
collection | PubMed |
description | 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 |
format | Online Article Text |
id | pubmed-5569491 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-55694912017-08-29 Vitamin D supplementation in cutaneous malignant melanoma outcome (ViDMe): a randomized controlled trial De Smedt, J. Van Kelst, S. Boecxstaens, V. Stas, M. Bogaerts, K. Vanderschueren, D. Aura, C. Vandenberghe, K. Lambrechts, D. Wolter, P. Bechter, O. Nikkels, A. Strobbe, T. Emri, G. Marasigan, V. Garmyn, M. BMC Cancer Study Protocol 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 BioMed Central 2017-08-23 /pmc/articles/PMC5569491/ /pubmed/28835228 http://dx.doi.org/10.1186/s12885-017-3538-4 Text en © The Author(s). 2017 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Study Protocol De Smedt, J. Van Kelst, S. Boecxstaens, V. Stas, M. Bogaerts, K. Vanderschueren, D. Aura, C. Vandenberghe, K. Lambrechts, D. Wolter, P. Bechter, O. Nikkels, A. Strobbe, T. Emri, G. Marasigan, V. Garmyn, M. Vitamin D supplementation in cutaneous malignant melanoma outcome (ViDMe): a randomized controlled trial |
title | Vitamin D supplementation in cutaneous malignant melanoma outcome (ViDMe): a randomized controlled trial |
title_full | Vitamin D supplementation in cutaneous malignant melanoma outcome (ViDMe): a randomized controlled trial |
title_fullStr | Vitamin D supplementation in cutaneous malignant melanoma outcome (ViDMe): a randomized controlled trial |
title_full_unstemmed | Vitamin D supplementation in cutaneous malignant melanoma outcome (ViDMe): a randomized controlled trial |
title_short | Vitamin D supplementation in cutaneous malignant melanoma outcome (ViDMe): a randomized controlled trial |
title_sort | vitamin d supplementation in cutaneous malignant melanoma outcome (vidme): a randomized controlled trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5569491/ https://www.ncbi.nlm.nih.gov/pubmed/28835228 http://dx.doi.org/10.1186/s12885-017-3538-4 |
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