CTRI/2020/08/026961招募中未知
Randomized double-blinded placebo-controlled clinical trial for the evaluation of effect of vitamin K supplementation on bone mineral density in prostate cancer patients - VKPC
AIIMS New Delhi0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Age>=18 years
- •2. Biopsy proven prostate cancer patients on ADT
排除标准
- •a.Patients who are not willing to participate and will not provide signed informed consent
- •b.Patients with gastrointestinal disorders such as peptic ulcer disease
- •c.History of hematemesis, hemoptysis, melena or hematuria
- •d.Patients with bleeding diathesis
- •e.Patients with connective tissue disorders like systemic lupus erythematosus, rheumatoid arthritis, systemic sclerosis and other autoimmune disorders
- •f.History of any bone fracture or metabolic bone disease or bone tumor
- •g.Use of any anticoagulant or warfarin
- •h.Thyrotoxicosis patients
- •i.Patients with hepatic dysfunction that is those in whom serum bilirubin will be more than 1.5 and, AST and ALT will be more than 2.5 fold higher than the upper limit of normal at baseline
- •j.Patients in whom serum creatinine will be more than 1.5 fold higher than the upper limit of normal
- •k.Patients with congestive cardiac failure, severe or unstable angina
- •l.Atrial Fibrillation, or other cardiac arrhythmia requiring medical therapy
- •m.Administration of an investigational therapeutic agent within 30 days of screening
- •n.Prior radiation therapy completed < 4 weeks prior to enrollment
- •o.Any currently active second malignancy. Patients are not considered to have a currently active malignancy, if they have completed therapy and are considered by their physician to be at least less than 30% risk of relapse over next year
- •p.Active psychiatric illnesses/social situations that would limit compliance with protocol requirements
- •q.Patients in whom urgent chemotherapy, in the opinion of the treating physician, is indicated
- •r.Visceral metastasis
研究者
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