Clinical trial NCT01748448: Vitamin D Supplementation in Cutaneous Malignant Melanoma Outcome
Official title: Vitamin D Supplementation in Cutaneous Malignant Melanoma Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cutaneous Malignant Melanoma
Keywords: Cutaneous malignant melanoma
Vitamin D
Cholecalciferol
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: KU Leuven
First posted: 2012-12-12
Enrollment: 436
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess whether vitamin D supplementation after surgery of a first cutaneous malignant melanoma protects against relapse of the disease.

Detailed description: To assess whether vitamin D supplementation, in the follow up period after diagnosis and surgery of a first cutaneous malignant melanoma, has a protective effect on relapse of cutaneous malignant melanoma and whether this protective effect correlates with vitamin D levels in serum and vitamin D receptor (VDR) immunoreactivity in the primary tumor.

Eligibility criteria: Inclusion Criteria:

1. Older than 18 years and younger than 80 years of age.
2. Histologically proven malignant melanoma, stage one B (IB) to three (III) Not participating in other clinical trial.
3. The only treatment for melanoma is surgical treatment.
4. Complete resection of melanoma.
5. Single primary invasive cutaneous melanoma
6. Signed ethical committee approved informed consent
7. Serum phosphate, serum calcium at the entry of the study within normal limits of laboratory reference

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, chronic renal disease with glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2 or renal dialysis.
4. Liver failure or chronic liver disease with liver enzymes \> 2 fold upper limit of normal (ULN).
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 small intestine resection.
8. 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 or in situ malignant melanoma.
9. Chronic alcohol abuse.
10. Medical or logistic problems likely to preclude completion of the study.
11. Taking medication that predisposes to hypercalcemia (digoxin, lithium, thiazide diuretics) or taking medication that would affect metabolism of vitamin D (anticonvulsants, corticosteroids, H2-receptor antagonists)
12. Intake of vitamin D supplements within 6 months prior to entry of the study.

Primary outcomes:
measure: Relapse Free Survival
timeFrame: study duration maximum 9 years and 7 months or until relapse
Secondary outcomes:
measure: Melanoma Subtype, as Assessed Clinically and Histologically
timeFrame: Time at diagnosis
measure: Melanoma Site, as Clinically Recorded
timeFrame: Time at diagnosis
measure: 25(OH)D3 Serum Levels
timeFrame: study duration maximum 3.5 years (Treatment period) or until relapse
measure: Stage of Melanoma Patient
timeFrame: Time at diagnosis
Other outcomes:
measure: Safety Endpoints:Incidence and Severity of Adverse Events
timeFrame: study duration maximum 3.5 years (Treatment period) or until relapse
Locations:
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen, Dermatology
city: Leuven
country: Belgium
facility: UZLeuven Gasthuisberg
city: Liège
country: Belgium
facility: Chef de Service du Service Universitaire de Dermatologie
city: Debrecen
country: Hungary
facility: Dep. of Dermatology, Medical and Health Science Center University of Debrecen
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Marjan Garmyn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: De Smedt J, Van Kelst S, Boecxstaens V, Stas M, Bogaerts K, Vanderschueren D, Aura C, Vandenberghe K, Lambrechts D, Wolter P, Bechter O, Nikkels A, Strobbe T, Emri G, Marasigan V, Garmyn M. Vitamin D supplementation in cutaneous malignant melanoma outcome (ViDMe): a randomized controlled trial. BMC Cancer. 2017 Aug 23;17(1):562. doi: 10.1186/s12885-017-3538-4.
citation: De Smedt J, Van Kelst S, Janssen L, Marasigan V, Boecxstaens V, Bogaerts K, Belmans A, Vanderschueren D, Vandenberghe K, Bechter O, Aura C, Lambrechts D, Strobbe T, Emri G, Nikkels A, Garmyn M. High-dose vitamin D supplementation does not improve outcome in a cutaneous melanoma population: results of a randomized double-blind placebo-controlled study (ViDMe trial). Br J Dermatol. 2024 Nov 18;191(6):886-896. doi: 10.1093/bjd/ljae257.
citation: De Smedt J, Aura C, Van Kelst S, Janssen L, Marasigan V, Boecxstaens V, Stas M, Bogaerts K, Belmans A, Cleynen I, Vanderschueren D, Vandenberghe K, Bechter O, Nikkels A, Strobbe T, Emri G, Lambrechts D, Garmyn M. Clinical and genetic determinants of vitamin D receptor expression in cutaneous melanoma patients. Melanoma Res. 2024 Apr 1;34(2):125-133. doi: 10.1097/CMR.0000000000000929. Epub 2024 Feb 13.
citation: De Smedt J, Van Kelst S, Janssen L, Marasigan V, Boecxstaens V, Stas M, Vanderschueren D, Guler I, Bogaerts K, Vandenberghe K, Bechter O, Billen J, Nikkels A, Strobbe T, Emri G, Lambrechts D, Garmyn M. Determinants of 25-hydroxyvitamin D Status in a Cutaneous Melanoma Population. Acta Derm Venereol. 2022 Apr 8;102:adv00692. doi: 10.2340/actadv.v102.262.