Vitamin D Supplementation in Cutaneous Malignant Melanoma Outcome

Cutaneous Malignant Melanoma Clinical Trial

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Official title:

Vitamin D Supplementation in Cutaneous Malignant Melanoma Outcome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01748448
• Other study ID #: 2012LRDVDCM
• Secondary ID: 2012-002125-30
• Status: Completed
• Phase: Phase 3
• Start date: December 2012
• Est. completion date: July 2022

Study information

• Verified date: March 2023
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 436
• Est. completion date: July 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cutaneous Malignant Melanoma
• Melanoma
• Skin Neoplasms

Intervention

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
• arachides oleum raffinatum

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Antwerpen, Dermatology	Edegem
Belgium	UZLeuven Gasthuisberg	Leuven
Belgium	Chef de Service du Service Universitaire de Dermatologie	Liège
Hungary	Dep. of Dermatology, Medical and Health Science Center University of Debrecen	Debrecen

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven	KU Leuven

Countries where clinical trial is conducted

Belgium,  Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety endpoints:Incidence and severity of adverse events	Incidence and severity of adverse events will be recorded every 3 months up to final study visit.	study duration maximum 3,5 years
Primary	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	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
Secondary	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
Secondary	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
Secondary	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