Status:
TERMINATED
MelaViD: A Trial on Vitamin D Supplementation for Resected Stage II Melanoma Patients
Lead Sponsor:
European Institute of Oncology
Conditions:
Melanoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of this trial is to assess the effect of vitamin D supplementation on recurrence in resected stage II melanoma patients.
Detailed Description
Cancer chemoprevention uses natural, synthetic, or biologic chemical agents to reverse, suppress, or prevent carcinogenic progression (Sporn MB Cancer Res 1976). Genetic changes exist throughout the f...
Eligibility Criteria
Inclusion
- 18-75 years old with newly diagnosed histologically proven resected melanoma
- Stage: IIa (T2b, T3a), IIb (T3b T4a) and IIc (T4b), N0, M0
- Signed informed Consent
- Willingness to provide blood samples
- Performance Status of 0-1
- Hematopoietic functionality at the entry of the study: leukocytes, platelets, haemoglobin and neutrophiles within the normal limits of laboratory references
- Hepatic and renal functionality at the entry of the study within the normal range of each laboratory
- Serum and urinary calcium within the upper limit of laboratory references.
Exclusion
- Primary not cutaneous melanoma
- Clinical/radiological evidence or laboratory/pathology report of not completely resected melanoma
- History of cancer (other than Carcinoma in situ (CIN) and non melanoma skin cancere (NMSC)
- Current daily use of at least 600 IU/day of supplemental vitamin D or calcitriol or high dose of calcium therapy (e.g. calcium citrate with vitamin D) within the prior 6 months greater than 600 mg calcium per day during study
- History of recurrent renal calculi or hypercalcemia (\>10mg/dl), current and chronic use of oral corticosteroids
- History of malabsorption syndrome (e.g., pancreatic insufficiency, celiac disease, Crohn disease or tropical sprue)
- History of small intestinal resection (e.g., ileal bypass surgery for treatment of morbid obesity resection \> 50 % of slim bowel)
- Hypersensitivity to cholecalciferol or one of its components
- Chronic liver disease, chronic renal disease, or renal dialysis
- History of parathyroid disease and sarcoidosis
- Pregnancy or breast feeding or planning on becoming pregnant during the 3 years of treatment
- Chronic alcoholism
- Any medical condition that in the physician's opinion would potentially interfere with vitamin D absorption, such as celiac sprue, ulcerative colitis, patients treated pharmacologically for obesity
- Any logistic condition that do not allow follow-up of the disease of the patient.
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2017
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01264874
Start Date
May 1 2010
End Date
July 1 2017
Last Update
January 31 2018
Active Locations (1)
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1
European Institute of Oncology
Milan, Italy, 20141