Vitamin D Supplementation in Cutaneous Malignant Melanoma Outcome

NCT01748448 | Completed Phase 3 Results DMC

• 2 other identifiers: 2012LRDVDCM2012-002125-30
• Study Type: interventional
• Target: 436
• Locations: 2 countries
• Sites: 4

Brief Summary

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

Conditions

Cutaneous Malignant Melanoma

Keywords

Cutaneous malignant melanoma; Vitamin D; Cholecalciferol

Outcome Measures

Primary Outcomes (1)

• Relapse Free Survival

  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.

  study duration maximum 9 years and 7 months or until relapse

Secondary Outcomes (4)

• Melanoma Subtype, as Assessed Clinically and Histologically

  Time at diagnosis

• Melanoma Site, as Clinically Recorded

  Time at diagnosis

• 25(OH)D3 Serum Levels

  study duration maximum 3.5 years (Treatment period) or until relapse

• Stage of Melanoma Patient

  Time at diagnosis

Other Outcomes (1)

• Safety Endpoints:Incidence and Severity of Adverse Events

  study duration maximum 3.5 years (Treatment period) or until relapse

Study Arms (2)

Vitamin D

ACTIVE COMPARATOR

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

Placebo: Oil

PLACEBO COMPARATOR

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: Placebo: Oil

Interventions

Vitamin D DRUG

* 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

Also known as: D-Cure, Cholecalciferol

Vitamin D

Placebo: Oil DRUG

Also known as: Placebo

Placebo: Oil

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• KU Leuven: collaborator

Study Sites (4)

Universitair Ziekenhuis Antwerpen, Dermatology

Edegem, 2650, Belgium

Location

UZLeuven Gasthuisberg

Leuven, 3000, Belgium

Location

Chef de Service du Service Universitaire de Dermatologie

Liège, 4000, Belgium

Location

Dep. of Dermatology, Medical and Health Science Center University of Debrecen

Debrecen, 4032, Hungary

Location

Related Publications (4)

• De Smedt J, Van Kelst S, Boecxstaens V, Stas M, Bogaerts K, Vanderschueren D, Aura C, Vandenberghe K, Lambrechts D, Wolter P, Bechter O, Nikkels A, Strobbe T, Emri G, Marasigan V, Garmyn M. Vitamin D supplementation in cutaneous malignant melanoma outcome (ViDMe): a randomized controlled trial. BMC Cancer. 2017 Aug 23;17(1):562. doi: 10.1186/s12885-017-3538-4.

  PMID: 28835228 BACKGROUND

• De Smedt J, Van Kelst S, Janssen L, Marasigan V, Boecxstaens V, Bogaerts K, Belmans A, Vanderschueren D, Vandenberghe K, Bechter O, Aura C, Lambrechts D, Strobbe T, Emri G, Nikkels A, Garmyn M. High-dose vitamin D supplementation does not improve outcome in a cutaneous melanoma population: results of a randomized double-blind placebo-controlled study (ViDMe trial). Br J Dermatol. 2024 Nov 18;191(6):886-896. doi: 10.1093/bjd/ljae257.

  PMID: 38913652 RESULT

• De Smedt J, Aura C, Van Kelst S, Janssen L, Marasigan V, Boecxstaens V, Stas M, Bogaerts K, Belmans A, Cleynen I, Vanderschueren D, Vandenberghe K, Bechter O, Nikkels A, Strobbe T, Emri G, Lambrechts D, Garmyn M. Clinical and genetic determinants of vitamin D receptor expression in cutaneous melanoma patients. Melanoma Res. 2024 Apr 1;34(2):125-133. doi: 10.1097/CMR.0000000000000929. Epub 2024 Feb 13.

  PMID: 38348498 RESULT

• De Smedt J, Van Kelst S, Janssen L, Marasigan V, Boecxstaens V, Stas M, Vanderschueren D, Guler I, Bogaerts K, Vandenberghe K, Bechter O, Billen J, Nikkels A, Strobbe T, Emri G, Lambrechts D, Garmyn M. Determinants of 25-hydroxyvitamin D Status in a Cutaneous Melanoma Population. Acta Derm Venereol. 2022 Apr 8;102:adv00692. doi: 10.2340/actadv.v102.262.

  PMID: 35312026 RESULT

MeSH Terms

Conditions

Melanoma, Cutaneous Malignant

Interventions

Vitamin D; Cholecalciferol

Condition Hierarchy (Ancestors)

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholestenes; Cholestanes; Sterols; Membrane Lipids; Lipids

Results Point of Contact

• Title: Prof. Dr. M. Garmyn
• Organization: UZLeuven

marjan.garmyn@uzleuven.be

0032 16 33 79 50

Study Officials

• Marjan Garmyn, MD, PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2012
• First Posted: December 12, 2012
• Study Start: December 1, 2012
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: February 17, 2025
• Results First Posted: February 17, 2025

Record last verified: 2023-03

Locations

HU (1); BE (3)