ViDMe: Vitamin D Supplementation in Cutaneous Malignant Melanoma Outcome

Sponsor

Universitaire Ziekenhuizen Leuven (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01748448

Collaborator

KU Leuven (Other)

500

Enrollment

Locations

Arms

132

Duration (Months)

125

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

Anticipated 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 :

Dec 1, 2012

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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 Other Names: Placebo

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

Other Names:

Placebo

Outcome Measures

Primary Outcome Measures

Relapse free survival [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

Melanoma subtype, as assessed clinically and histologically [study duration maximum 3,5 years]
Vitamin D levels at diagnosis will be correlated with melanoma subtype, as assessed clinically and histologically.
Melanoma site, as clinically recorded [study duration maximum 3,5 years]
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]
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
Stage of melanoma patient [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

Safety endpoints:Incidence and severity of adverse events [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

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Universitair Ziekenhuis Antwerpen, Dermatology	Edegem	Belgium	2650
2	UZLeuven Gasthuisberg	Leuven	Belgium	3000
3	Chef de Service du Service Universitaire de Dermatologie	Liège	Belgium	4000
4	Dep. of Dermatology, Medical and Health Science Center University of Debrecen	Debrecen	Hungary	4032