Vitamin D Supplementation in Cutaneous Malignant Melanoma Outcome (ViDMe)

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Cutaneous Malignant Melanoma	Drug: Vitamin D; Drug: arachides oleum raffinatum	Phase 3

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 Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	500 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Vitamin D Supplementation in Cutaneous Malignant Melanoma Outcome
Study Start Date :	December 2012
Estimated Primary Completion Date :	September 2023
Estimated Study Completion Date :	December 2023

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: 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	Drug: Vitamin D; 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; Other Names: D-Cure; Cholecalciferol
Placebo Comparator: arachides oleum raffinatum; 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

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Relapse free survival [ Time Frame: study duration maximum 3,5 years ]
   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.

Secondary Outcome Measures :

1. Melanoma subtype, as assessed clinically and histologically [ Time Frame: study duration maximum 3,5 years ]
   Vitamin D levels at diagnosis will be correlated with melanoma subtype, as assessed clinically and histologically.
2. Melanoma site, as clinically recorded [ Time Frame: study duration maximum 3,5 years ]
   Vitamin D levels at diagnosis will be correlated with melanoma site, as clinically recorded.
3. 25(OH)D3 serum levels [ Time Frame: study duration maximum 3,5 years ]
   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
4. Stage of melanoma patient [ Time Frame: study duration maximum 3,5 years ]
   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

Other Outcome Measures:

1. Safety endpoints:Incidence and severity of adverse events [ Time Frame: study duration maximum 3,5 years ]
   Incidence and severity of adverse events will be recorded every 3 months up to final study visit.

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Marjan Garmyn, MD, PhD	+32 16337950 ext 37950	marjan.garmyn@uzleuven.be
Contact: Julie Desmedt, MD	+32 16337864 ext 37864	Julie.Desmedt@uzleuven.be

Locations

Belgium
Universitair Ziekenhuis Antwerpen, Dermatology	Active, not recruiting
Edegem, Belgium, 2650
UZ Sint Rafael ( UZLeuven)	Recruiting
Leuven, Belgium, 3000
Contact: Marjan Garmyn, MD PhD +3216337950 ext 37950 marjan.garmyn@uzleuven.be
Contact: Julie De Smedt, MD +3216337864 ext 37864 Julie.Desmedt@uzleuven.be
Principal Investigator: Marjan Garmyn, MD, PhD
Chef de Service du Service Universitaire de Dermatologie	Active, not recruiting
Liège, Belgium, 4000
Hungary
Dep. of Dermatology, Medical and Health Science Center University of Debrecen	Active, not recruiting
Debrecen, Hungary, 4032

Sponsors and Collaborators

Universitaire Ziekenhuizen Leuven

Katholieke Universiteit Leuven

Investigators

Principal Investigator:	Marjan Garmyn, MD, PhD	Universitaire Ziekenhuizen Leuven

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:	NCT01748448 History of Changes
Other Study ID Numbers:	2012LRDVDCM; 2012-002125-30 ( EudraCT Number )
First Posted:	December 12, 2012
Last Update Posted:	October 25, 2017
Last Verified:	October 2016

Keywords provided by Universitaire Ziekenhuizen Leuven:

Cutaneous malignant melanoma; Vitamin D; Cholecalciferol

Additional relevant MeSH terms:

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas	Vitamins; Vitamin D; Ergocalciferols; Cholecalciferol; Micronutrients; Growth Substances; Physiological Effects of Drugs; Bone Density Conservation Agents