Trial reportBMC cancer2014
Adjuvant therapy with high dose vitamin D following primary treatment of melanoma at high risk of recurrence: a placebo controlled randomised phase II trial (ANZMTG 02.09 Mel-D).
Trial report in BMC cancer, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
19 citing papers in PubMed, 39 citations in OpenAlex.
- 25-hydroxyvitamin D serum levels in patients with high risk resected melanoma treated in an adjuvant bevacizumab trial.British journal of cancer · 2018Trial
- Vitamin D supplementation in cutaneous malignant melanoma outcome (ViDMe): a randomized controlled trial.BMC cancer · 2017Trial
- Review
- Vitamin D in Melanoma: Potential Role of Cytochrome P450 Enzymes.Life (Basel, Switzerland) · 2024Review
- Protective role of vitamin D3 in a rat model of hyperthyroid-induced cardiomyopathy.Journal of traditional and complementary medicine · 2023Article
- Consideration of possible effects of vitamin D on established cancer, with reference to malignant melanoma.Pigment cell & melanoma research · 2022Review
- Metabolic Alterations and Therapeutic Opportunities in Rare Forms of Melanoma.Trends in cancer · 2021Review
- The Role of the Vitamin D Receptor in the Pathogenesis, Prognosis, and Treatment of Cutaneous Melanoma.Frontiers in oncology · 2021Review
- Current Molecular Markers of Melanoma and Treatment Targets.International journal of molecular sciences · 2020Review
- Sleep duration is associated with vitamin D deficiency in older women living in Macao, China: A pilot cross-sectional study.PloS one · 2020Article
- Relevance of Vitamin D in Melanoma Development, Progression and Therapy.Anticancer research · 2020Review
- Vitamin D and its low calcemic analogs modulate the anticancer properties of cisplatin and dacarbazine in the human melanoma A375 cell line.International journal of oncology · 2019Article
- On the role of classical and novel forms of vitamin D in melanoma progression and management.The Journal of steroid biochemistry and molecular biology · 2018Review
- Vitamin D signaling and melanoma: role of vitamin D and its receptors in melanoma progression and management.Laboratory investigation; a journal of technical methods and pathology · 2017Review
- Noncalcemic 20-hydroxyvitamin D3 inhibits human melanoma growth in in vitro and in vivo models.Oncotarget · 2017Article
- Article
- The Use of 1α,25-Dihydroxyvitamin D₃ as an Anticancer Agent.International journal of molecular sciences · 2016Review
- Vitamins and Melanoma.Cancers · 2015Review
- Clinicopathological features, vitamin D serological levels and prognosis in cutaneous melanoma of shield-sites: an update.Medical oncology (Northwood, London, England) · 2015Observational
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPatients with primary cutaneous melanomas that are ulcerated and >2 mm in thickness, >4 mm in thickness and those with nodal micrometastases at diagnosis, have few options for adjuvant treatment. Recent studies have suggested a role for vitamin D to delay melanoma recurrence and improve overall prognosis. METHODS/
designThis is a pilot placebo-controlled randomised phase II trial to assess the feasibility, safety and toxicity of an oral loading dose of Vitamin D (500,000 IU) followed by an oral dose of 50,000 IU of Vitamin D monthly for 2 years in patients who have been treated for cutaneous melanoma by wide excision of the primary. Patients aged 18-79 years who have completed primary surgical treatment and have Stage IIb, IIc, IIIa (N1a, N2a) or IIIb (N1a, N2a) disease are eligible for randomisation 2:1 to active treatment or placebo. The primary endpoints are sufficiency of dose, adherence to study medication and safety of the drug. The secondary endpoints are participation and progression free survival. The study has been approved by the Ethics Review Committee (RPAH Zone) of the Sydney Local Health District, protocol number X09-0138. DISCUSSION: Effective, non-toxic adjuvant therapy for high risk primary melanoma is not currently available. Favorable outcomes of this phase II study will form the basis for a multi-centre phase III study to assess whether the addition of oral high-dose vitamin D therapy in patients who have completed primary treatment for melanoma and are at high risk of recurrence will: 1. prolong time to recurrence within 5 years 2. improve overall survival at 5 years and 3. be both safe and tolerable. 62 patients have been randomised since the study commenced in December 2010. Target accrual for the study has been met with 75 patients randomised between December 2010 and August 2014.The Mel-D trial is conducted by the Australia and New Zealand Melanoma Trials Group (ANZMTG 02.09)
trial registrationAustralia and New Zealand Clinical Trials Registry (ANZCTR) ACTRN12609000351213.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.