CompletedPhase 2ACTRN12609000351213

Vitamin D following primary treatment of melanoma at high risk of recurrence

Assessing the feasibility, safety and toxicity of vitamin D following primary treatment of melanoma at high risk of recurrence: A pilot placebo controlled randomised phase II trial


Sponsor

Melanoma and Skin Cancer Trial

Enrollment

75 participants

Start Date

Jan 17, 2011

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 79 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether taking high-dose vitamin D after melanoma surgery can reduce the risk of the cancer returning. It is for adults aged 18 to 79 with stage II or III melanoma that has been surgically removed. Participation involves taking daily vitamin D or placebo capsules for two years with regular follow-up visits every four months.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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-adminstra

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.


Locations(2)

Royal Prince Alfred Hospital - Camperdown

NSW, Australia

The Poche Centre, Melanoma Institute Australia - North Sydney

NSW, Australia

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ACTRN12609000351213