EUCTR2010-022897-14-GB进行中（未招募）1 期
A feasibility study of Multimodal Exercise/Nutrition/Anti-inflammatory treatment for Cachexia – the pre-MENAC study - Pre-MENAC Study
Greater Glasgow Health Board0 个研究点目标入组 46 人开始时间: 2011年10月4日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 46
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1.Diagnosis of non operable non-small cell lung cancer (NSCLC) (stage III-IV) or pancreatic cancer
- •2.Due to commence chemotherapy or chemoradiotherapy
- •3.Have a staging CT within 4 weeks of commencement of chemotherapy or chemoradiotherapy
- •4.All baseline assessments can be completed within 2 weeks prior to first cycle of chemotherapy or chemoradiotherapy
- •5.18–75 years of age
- •6.A life expectancy of =4 months and is believed to be able to complete 2 months of intervention (based on clinical judgement)
- •7.Karnofsky Performance Score = 70
- •8.Written informed consent
- •9.Able to provide a blood sample
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 12
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8
排除标准
- •1.Neuro-endocrine pancreatic cancer
- •2.Renal impairment(serumalbumin < 25 g/L eller Child-Pugh =10), creatinine clearance <30ml/min (estimated using cockcroft-gault, creatinine measured within two months of date of consent)
- •3.Receiving parenteral nutrition or enteral nutrition via feeding tube
- •4.Weight loss >20% over the previous 6 months
- •5.BMI >30 kg/m2
- •6.Severe anorexia (less than 50% pre-illness food intake and unable to take oral supplements)
- •7.Use of appetite stimulants (such as megestrol acetate, progestational agents, growth hormone, dronabinol, marijuana or other anabolic agent) within 30 days prior to study baseline
- •8.Concomitant long term steroid treatment (inhaled, optical or pulsed oral steroids (up to 10 days use) are permitted).
- •9.Concomitant long term NSAID or Aspirin treatment.
- •10.Regularly scheduled on kinase inhibitors (e.g. sorafinib)
- •11.Women during pregnancy, breastfeeding or who are in child-bearing age and do not use adequate contraception
- •12.Positive history of heart disease, i.e., severe (New York Heart Association Functional class III or IV) heart failure, uncontrolled hypertension (diastolic blood pressure >95 mmHg at screening), history of previous myocardial infarction, unstable angina, coronary revascularization, uncontrolled arrhythmia, and cerebrovascular accident
- •13.Previous gastrointestinal inflammatory disease and history of gastrointestinal ulceration
- •14.History of bronchospasm, asthma, rhinitis, nasal polyps, angioneurotic oedema or urticaria with intake of NSAID or aspirin therapy
- •15.History of hyper sensibility related to intake of acetylsalisylsyre or NSAIDs, including COX-2 (cyklooksygenase-2) inhibitors.
- •16.History of hyper sensibility to Sulphonamides
- •17.Ongoing/planned radiotherapy during the study period affecting the gastric/oesophagus area
研究者
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