MelaViD: A Trial on Vitamin D Supplementation for Resected Stage II Melanoma Patients

• Status: Terminated
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to assess the effect of vitamin D supplementation on recurrence in resected stage II melanoma patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Institute of Oncology
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

1. 18-75 years old with newly diagnosed histologically proven resected melanoma

2. Stage: IIa (T2b, T3a), IIb (T3b T4a) and IIc (T4b), N0, M0

3. Signed informed Consent

4. Willingness to provide blood samples

5. Performance Status of 0-1

6. Hematopoietic functionality at the entry of the study: leukocytes, platelets, haemoglobin and neutrophiles within the normal limits of laboratory references

7. Hepatic and renal functionality at the entry of the study within the normal range of each laboratory

8. Serum and urinary calcium within the upper limit of laboratory references.

Exclusion Criteria:

1. Primary not cutaneous melanoma

2. Clinical/radiological evidence or laboratory/pathology report of not completely resected melanoma

3. History of cancer (other than Carcinoma in situ (CIN) and non melanoma skin cancere (NMSC)

4. 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

5. History of recurrent renal calculi or hypercalcemia (>10mg/dl), current and chronic use of oral corticosteroids

6. History of malabsorption syndrome (e.g., pancreatic insufficiency, celiac disease, Crohn disease or tropical sprue)

7. History of small intestinal resection (e.g., ileal bypass surgery for treatment of morbid obesity resection > 50 % of slim bowel)

8. Hypersensitivity to cholecalciferol or one of its components

9. Chronic liver disease, chronic renal disease, or renal dialysis

10. History of parathyroid disease and sarcoidosis

11. Pregnancy or breast feeding or planning on becoming pregnant during the 3 years of treatment

12. Chronic alcoholism

13. 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

14. Any logistic condition that do not allow follow-up of the disease of the patient.