None listed
Conditions
Brief summary
This study aims to evaluate the safety and efficacy of high dose vitamin D therapy in patients who have primary melanoma which has been treated and are at high risk of recurrence. Who is it for? You may be eligible to join this study if you aged 18 to 79 years and have been diagnosed with cutaneous melanoma. Study details: Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will receive vitamin D3 tablets monthly for 24 months, whilst participants in the other group will receive a placebo (sugar pill). Participants will be followed-up for 24 months, in order to determine dose sufficiency, compliance, safety and progression free survival.
Interventions
Oral vitamin D3 tablets (Calciferol D Forte 1.25mg) 50 000IU or matching placebo administered during first study visit post-randomisation (10 tablets administered in total). Thereafter, self-adminstration of one vitamin D3 tablet (Calciferol D Forte) 50 000IU by patients on first day of every month for 23 months.
Sponsors
Melanoma and Skin Cancer Trial
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
i) Primary, histologically confirmed resected stage IIb, IIc, IIIa (N1a) and IIIb (N1a, N2a) cutaneous melanoma ii) Wide excision or if there is no wide excision, excision of the primary lesion with clear pathological marigins <90 days prior to randomisation iii) Serum corrected calcium and urinary calcium to creatinine ratio within normal range for testing laboratory iv) Serum creatinine <=1.5 times the institutional upper limit of normal and estimated Glomerular Filtration Rate (eGFR) within normal range for testing laboratory. v) Serum Low-density Lipoprotein <1.5 upper limit of normal (ULN) vi) Able to provide written informed consent vii) Geographically accessible and willing and able to attend 4 monthly folllow-up visits at Sydney Melanoma Unit (SMU) for 2 years viii) Performance status - Eastern Cooperative Oncology Group (ECOG) score between 0 and 2
Exclusion criteria
i) Patients with a known history of renal calculi ii) Patients with a known history of hyperthyroidism iii) Patients who have a concomitant invasive cancer other than basal cell carcinoma of the skin or localised squamous cell carcinoma of the skin or a previous such cancer and have been cancer free for less than 5 years iv) Any of the following laboratory results (tests must not have been carried out more than 4 weeks prior to randomisation) Absolute neutrophil count (ANC) <1.5 x 10 (to the power of 9)/l Platelet count <100 x 10 (to the power of 9)/l Total bilirubin >1.5 upper limit of normal (ULN) Aspartate Amino Transferase (AST), Alanine Amino Transferase (ALT), Alkaline Phosphate (Alk Phos) >2.5 upper limit of normal (ULN) v) Patients who are pregnant or lacatating. Women of child bearing potential must have a confirmed negative pregnancy test at study entry vi) Patients with a medical or psychological problem which, in the investigators' opinion, would interfere with treatment or follow-up vii) Patients with either ocular or mucosal melanoma viii) Patients who are currently enrolled in other concurrent experimental treatments or alternative therapies ix) Patients cannot have received any other investigational agents or treatment (i.e. chemo, immuno, vaccine or radio therapy) within 30 days of commencing study x) Patients should not be taking other agents known to interact with the study drug such as anti-convulsants
Outcome results
None listed