Vitamin D Supplementation in Cutaneous Malignant Melanoma Outcome
Overview
- Phase
- Phase 3
- Intervention
- Vitamin D
- Conditions
- Cutaneous Malignant Melanoma
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Enrollment
- 436
- Locations
- 4
- Primary Endpoint
- Relapse Free Survival
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
To assess whether vitamin D supplementation after surgery of a first cutaneous malignant melanoma protects against relapse of the disease.
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.
Investigators
Eligibility Criteria
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.
Exclusion Criteria
- Not provided
Arms & Interventions
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
Intervention: Vitamin D
Outcomes
Primary Outcomes
Relapse Free Survival
Time Frame: study duration maximum 9 years and 7 months or until relapse
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.
Secondary Outcomes
- 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)