Vitamin D Supplementation in Cutaneous Malignant Melanoma Outcome

Phase 3

Completed

• Conditions: Cutaneous Malignant Melanoma
• Interventions: Drug: Vitamin D

• Registration Number: NCT01748448
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-05
• Study First Submitted QC: 2012-12-11
• Study First Posted: 2012-12-12
• Primary Completion: 2022-07
• Study Completion: 2022-07
• Status Verified: 2023-03
• Results First Submitted: 2024-10-08
• Results First Submitted QC: 2025-01-30
• Last Update Submitted: 2025-01-30
• Results First Posted: 2025-02-17
• Last Update Posted: 2025-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 436

Inclusion Criteria

1. Older than 18 years and younger than 80 years of age.
2. Histologically proven malignant melanoma, stage one B (IB) to three (III) Not participating in other clinical trial.
3. The only treatment for melanoma is surgical treatment.
4. Complete resection of melanoma.
5. Single primary invasive cutaneous melanoma
6. Signed ethical committee approved informed consent
7. Serum phosphate, serum calcium at the entry of the study within normal limits of laboratory reference

Exclusion criteria

1. Pregnant/lactating women or planning on becoming pregnant during the study
2. Known hypersensitivity to vitamin D or its components.
3. Pre-existing renal stone disease, chronic renal disease with glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 or renal dialysis.
4. Liver failure or chronic liver disease with liver enzymes > 2 fold upper limit of normal (ULN).
5. History of parathyroid disease or granulomatous disease (TBC and sarcoidosis)
6. History of malabsorption syndrome or any medical condition that might interfere with vitamin D absorption.
7. History of small intestine resection.
8. 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.
9. Chronic alcohol abuse.
10. Medical or logistic problems likely to preclude completion of the study.
11. 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)
12. Intake of vitamin D supplements within 6 months prior to entry of the study.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D	Vitamin D	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

Primary Outcome Measures

Name	Time	Method
Relapse Free Survival	study duration maximum 9 years and 7 months or until relapse	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.

Secondary Outcome Measures

Name	Time	Method
Melanoma Subtype, as Assessed Clinically and Histologically	Time at diagnosis	Vitamin D levels at diagnosis will be correlated with melanoma subtype, as assessed clinically and histologically.
Melanoma Site, as Clinically Recorded	Time at diagnosis	Vitamin D levels at diagnosis will be correlated with melanoma site, as clinically recorded.
25(OH)D3 Serum Levels	study duration maximum 3.5 years (Treatment period) or until relapse	25(OH)D3 serum levels will be recorded at diagnosis and at 6 months intervals up to final study visit.
Stage of Melanoma Patient	Time at diagnosis	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.

Trial Locations

Locations (4)

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