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Vitamin D Supplementation in Cutaneous Malignant Melanoma Outcome (ViDMe)

This study is currently recruiting participants.
Verified November 2012 by Universitaire Ziekenhuizen Leuven
Sponsor:
Collaborator:
Katholieke Universiteit Leuven
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01748448
First received: December 5, 2012
Last updated: March 18, 2013
Last verified: November 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Cutaneous Malignant Melanoma
 Drug: Vitamin D
Drug: arachides oleum raffinatum
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vitamin D Supplementation in Cutaneous Malignant Melanoma Outcome

Resource links provided by NLM:

MedlinePlus related topics: Melanoma Vitamin D
U.S. FDA Resources

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Relapse free survival [ Time Frame: study duration maximum 3,5 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: study duration maximum 3,5 years ] [ Designated as safety issue: No ]
    Vitamin D levels at diagnosis will be correlated with melanoma subtype, as assessed clinically and histologically.

  • Melanoma site, as clinically recorded [ Time Frame: study duration maximum 3,5 years ] [ Designated as safety issue: No ]
    Vitamin D levels at diagnosis will be correlated with melanoma site, as clinically recorded.

  • 25(OH)D3 serum levels [ Time Frame: study duration maximum 3,5 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: study duration maximum 3,5 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: study duration maximum 3,5 years ] [ Designated as safety issue: Yes ]
    Incidence and severity of adverse events will be recorded every 3 months up to final study visit.


Estimated Enrollment: 500
Study Start Date: December 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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 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.
  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01748448

Contacts
Contact: Marjan Garmyn, MD, PhD +32 16337950 ext 37950 marjan.garmyn@uzleuven.be
Contact: Vivien Marasigan, MD +32 16337950 ext 37950 vivien.marasigan@zleuven.be

Locations
Belgium
UZ Sint Rafael ( UZLeuven) Recruiting
Leuven, Belgium, 3000
Contact: Marjan Garmyn, MD PhD     +3216337950 ext 37950     marjan.garmyn@uzleuven.be    
Contact: Vivien Marasigan, MD     +3216337950 ext 37950     Vivien.Marasigan@uzleuven.be    
Principal Investigator: Marjan Garmyn, MD, PhD            
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Katholieke Universiteit Leuven
Investigators
Principal Investigator: Marjan Garmyn, MD, PhD Universitaire Ziekenhuizen Leuven
  More Information

No publications provided

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01748448     History of Changes
Other Study ID Numbers: 2012LRDVDCM, 2012-002125-30
Study First Received: December 5, 2012
Last Updated: March 18, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Universitaire Ziekenhuizen Leuven:
Cutaneous malignant melanoma
Vitamin D
Cholecalciferol

Additional relevant MeSH terms:
Melanoma
Skin Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms by Site
 Skin Diseases
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 22, 2013