Comparative Evaluation of Methadone and Morphine in Managing Breathlessness, Pain and Quality of life in Lung Carcinoma Patients- A Randomised control trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- To assess and compare the efficacy of methadone and morphine in managing breathlessness using Visual Analogue Scale.
研究概览
简要总结
**INTRODUCTION:**According to WHO, Globally Lung cancer is the most common cancer type and the most common cause of cancer death. In India, among cancer incidence in males, lung cancer ranked the highest. The major symptoms in lung cancer are Cough, Chest pain, Breathlessness, Anorexia and fatigue. The prevalence of breathlessness in primary lung cancers is more than 70%.Among opioids, low dose Morphine is standard therapy in relieving breathlessness in Cancer, COPD and Heart failure patients. There are some case series that demonstrated Methadone effect in breathlessness but not well established. As, Methadone is comparatively more cheaper and more potent than Morphine , knowledge and experience in using Methadone for breathlessness and pain will reduce symptom burden in economically poor cancer patients and patients with severe symptoms.
**AIM:**To assess and compare the efficacy of methadone and morphine in managing breathlessness, pain and quality of life in Lung Cancer patients. This study is an open labelled, Randomized control trial, planned as a Non Inferiority trail
METHADOLOGY:
Ø Patients diagnosed with Carcinoma Lung will be selected using inclusion and exclusion criteria .
Ø Informed consent will be obtained and then patients randomly distributed in Study arm and Control arm using the random numbers generated through online software- Research Randomizer.
Ø Patients will be started initially with, Syrup Methadone 2.5mg BD in Study arm and Tablet Morphine (IR) 5mg TDS in Control arm Then gradually uptitrated based on symptom response.
Ø The baseline symptom burden score for Breathlessness, Pain and Quality of Life will be assessed using Visual Analogue Scale(VAS), Numerical Rating Scale (NRS) and EORTC QLQ-C30 & EORTC QLQ-LC29 Questionnaire respectively
Ø The efficacy of Methadone and Morphine in treating Breathlessness, Pain and Quality of Life will be assessed with baseline and different predefined time points.
Ø The collected data will be analysed with the use of SPSS 29 or STATA 18. Quantitative data will be presented in Mean with Standard deviation (SD) or Median with Interquartile Range. A p-value of less than 0.05 will be considered as Statistical significance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.All the patients diagnosed with Lung cancer with age greater than 18 years.
- •2.Patients with Dyspnoea of MMRC grade greater than
- •3.Ability to provide informed consent to participate in the study.
- •4.Patients fall under Eastern Cooperative Oncology Group performance status classification I to III.
排除标准
- •1.Patients who are already getting treated with WHO Step 3 Analgesics. 2.Patients diagnosed with Chronic Kidney disease or Deranged renal function test.
- •Serum Urea lab value greater than 50mg/dL and Serum Creatinine lab value greater than 1.4mg/dL. 3.Patients with deranged liver function test.
- •liver enzymes- SGOT lab value greater than 115U/L, SGPT lab value greater than 150U/L and ALP lab value greater than 350U/L 4.Patients with Significant Electrolyte abnormalities with symptoms. 5.Patients with Prolonged QTc interval.
- •value greater than 450 in ECG.
结局指标
主要结局
To assess and compare the efficacy of methadone and morphine in managing breathlessness using Visual Analogue Scale.
时间窗: To assess and compare the efficacy of methadone and morphine in managing breathlessness using Visual Analogue Scale- at Baseline/Pre-intervention, Post Intervention- Day 1, Day 7 and Day 14
次要结局
- 1.To assess and compare the efficacy of methadone and morphine in Pain management using Numerical Rating Scale.(2.Assessing Quality of life using the EORTC QLQ-C30 and EORTC QLQ-LC29 questionnaires.)
研究者
Dr Tilak R
All India Institute of Medical Sciences, New Delhi