Vitamin D Supplementation in Cutaneous Malignant Melanoma Outcome

Study Overview
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Brief Summary
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To assess whether vitamin D supplementation after surgery of a first cutaneous malignant melanoma protects against relapse of the disease.

Detailed Description
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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.

Official Title
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Vitamin D Supplementation in Cutaneous Malignant Melanoma Outcome

Conditions
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Cutaneous Malignant Melanoma

Intervention / Treatment
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* Drug: Vitamin D
* Drug: arachides oleum raffinatum


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Older than 18 years and younger than 80 years of age. Histologically proven malignant melanoma, stage one B (IB) to three (III) Not participating in other clinical trial. The only treatment for melanoma is surgical treatment. Complete resection of melanoma. Single primary invasive cutaneous melanoma Signed ethical committee approved informed consent Serum phosphate, serum calcium at the entry of the study within normal limits of laboratory reference Exclusion criteria Pregnant/lactating women or planning on becoming pregnant during the study Known hypersensitivity to vitamin D or its components. Pre-existing renal stone disease, chronic renal disease with glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 or renal dialysis. Liver failure or chronic liver disease with liver enzymes > 2 fold upper limit of normal (ULN). History of parathyroid disease or granulomatous disease (TBC and sarcoidosis) History of malabsorption syndrome or any medical condition that might interfere with vitamin D absorption. History of small intestine resection. History of other malignancy within the last 5 years except for carcinoma in situ of the cervix or basal cell carcinoma or squamous cell carcinoma of the skin or in situ malignant melanoma. Chronic alcohol abuse. Medical or logistic problems likely to preclude completion of the study. Taking medication that predisposes to hypercalcemia (digoxin, lithium, thiazide diuretics) or taking medication that would affect metabolism of vitamin D (anticonvulsants, corticosteroids, H2-receptor antagonists) Intake of vitamin D supplements within 6 months prior to entry of the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vitamin D<br>Every month 100 000 units of Vitamin D in syringe oral dispenser is taken . Study duration is maximum 3,5 years or until relapse occurs | Drug: Vitamin D<br>* 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<br>* Other names: Cholecalciferol;|
| Placebo Comparator: arachides oleum raffinatum<br>Every month 100 000 units of vitamin D in syringe Oral dispenser is taken. Study duration is maximum of 3.5 years or until relapse occurs | Drug: arachides oleum raffinatum<br> <br> * Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse free survival | Disease free survival will be the primary endpoint of this phase III trial. Patients are enrolled during a recruitment phase of three years maximum. Study duration for one patient is maximum 3,5 years or until relapse occurs. | study duration maximum 3,5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Melanoma subtype, as assessed clinically and histologically | Vitamin D levels at diagnosis will be correlated with melanoma subtype, as assessed clinically and histologically. | study duration maximum 3,5 years | 
| Melanoma site, as clinically recorded | Vitamin D levels at diagnosis will be correlated with melanoma site, as clinically recorded. | study duration maximum 3,5 years | 
| 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. Genetic variability of Vitamin D pathway will be correlated with 25(OH)D3 serum levels | study duration maximum 3,5 years | 
| Stage of melanoma patient | Vitamin D levels at diagnosis and genetic variability of the vitamin D pathway will be correlated with stage of melanoma patient at diagnosis according to the 2009 American Joint Committee of Cancer (AJCC) Melanoma staging and classification | study duration maximum 3,5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cutaneous malignant melanoma, Vitamin D, Cholecalciferol