Therapeutic effect of the intake high dose Vitamin D on the outcome of malignant melanoma of the ski

• Conditions: cutaneous malignant melanoma; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-002125-30-HU
• Lead Sponsor: ZLeuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-27
• Last Update Posted: 10 March 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1.Older than 18 years and younger than 80 years of age.
2.Histologically proven malignant melanoma, stage IB to 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 (inclusion within 1 year after diagnosis).
6.Signed ethical committee approved informed consent
7.Serum phosphate and calcium at the entry of the study within normal range of the laboratory reference

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

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 or chronic renal disease with eGRF < 30 mL/min/1.73 m2 or renal dialysis.
4.Liver failure or chronic liver disease with liver enzyme > 2 fold ULN (=upper limit of normal)
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 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.
8.Chronic alcohol abuse.
9.Medical or logistic problems likely to preclude completion of the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified