To assess whether vitamin D supplementation after surgery of a first cutaneous malignant melanoma protects against relapse of the disease.
To assess whether vitamin D supplementation, in the follow up period after diagnosis and surgery of a first cutaneous malignant melanoma, 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 (VDR) immunoreactivity in the primary tumor.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
436
* prospective interventional randomized double blind placebo controlled trail * clinical setting (tertiary university hospital) * investigator driven, no pharmaceutical sponsor * cutaneous malignant melanoma patients * add- on study (placebo or vitamin D) on top of optimal standard care * 1:1 inclusion ratio (placebo:Vitamin D) * randomisation after informed consent and screening
Universitair Ziekenhuis Antwerpen, Dermatology
Edegem, Belgium
UZLeuven Gasthuisberg
Leuven, Belgium
Chef de Service du Service Universitaire de Dermatologie
Liège, Belgium
Dep. of Dermatology, Medical and Health Science Center University of Debrecen
Debrecen, Hungary
Relapse Free Survival
Disease free survival will be the primary endpoint of this phase III trial. Study duration for one patient is maximum 9 years and 7 months. Patients are supplemented with studymedication (Vitamin D or placebo) for maximum 3.5 years. This is the treatment period. After the treatment period (in which the patients take study medication, placebo or Vitamin D), there is the follow-up period, no more study medication is taken, the study is still double blind, and the patients are followed at the clinical department for relapse and/or death.
Time frame: study duration maximum 9 years and 7 months or until relapse
Melanoma Subtype, as Assessed Clinically and Histologically
Vitamin D levels at diagnosis will be correlated with melanoma subtype, as assessed clinically and histologically.
Time frame: Time at diagnosis
Melanoma Site, as Clinically Recorded
Vitamin D levels at diagnosis will be correlated with melanoma site, as clinically recorded.
Time frame: Time at diagnosis
25(OH)D3 Serum Levels
25(OH)D3 serum levels will be recorded at diagnosis and at 6 months intervals up to final study visit.
Time frame: study duration maximum 3.5 years (Treatment period) or until relapse
Stage of Melanoma Patient
Stage of melanoma patient at diagnosis according to the 8th American Joint Committee of Cancer (AJCC) Melanoma staging and classification. The eighth edition of the AJCC staging system is currently the most widely accepted and standardized approach to melanoma staging and classification at initial diagnosis. Melanoma staging is based on the American Joint Committee on Cancer (AJCC) staging system that uses three key pieces of information for assigning Tumor-Node-Metastasis (TNM) classifications. AJCC staging ifacilitates accurate risk stratification and is essential to guide patient treatment. The higher the stage, the more severe the melanoma.
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Time frame: Time at diagnosis