comparative efficacy of Polyethylene glycol and Bisacodyl as prophylactic agents for opioid induced constipation in cancer patients initiated on morphine therapy
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 253
- 试验地点
- 2
- 主要终点
- To compare the effectiveness of polyethylene glycol and bisacodyl in preventing opioid induced constipation in cancer patients initiating morphine therapy. The primary endpoint is the incidence of opioid induced constipation, as assessed by revised victoria bowel performance scale.
研究概览
简要总结
Despite the availability of multiple treatment options, theres is a pressing need for well designed clinical studies that directly compare the efficacy and safety of these therapies, especially in cancer patient receiving opioid. the present study is designed to compare polyethylene glycol and bisacodyl in preventing opioid induced constipation in cancer patients initiating morphine for cancer related pain by assessing metrics like stool frequency, stool form, patient satisfaction and any treatment related side effects.
A total of 253 patients visiting palliative medicine OPD will be recruited for the study as per the inclusion and exclusion criteria. online software based block randomization will be done to allot patients into two groups. group A will receive polyethylene glycol and group will get bisacodyl. patients will be assessed at baseline and then followed up at day 15, day 30 and day 90th post intervention. The findings of this investigation aim to aid clinicians in making informed treatment choices and improving outcomes of patients suffering from this challenging condition.
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 90.00 Year(s)（—）
- 性别
- All
入选标准
- •All cancer patient whose performance status is more than 70%,life expectancy more than 12 week and plan to initiated on morphine therapy.
- •All patient who can understand Hindi/English.
排除标准
- •Age below 18 years.
- •patient with a known history of gastrointestinal obstruction or perforation.
- •presence of non opioid related causes of constipation(eg.
- •hypothyroidism, neurological disorders).
- •Patients with renal or hepatic failure affecting drug metabolism or excretion.
- •5.Known hypersensitivity to Polyethylene glycol or Bisacodyl.
- •pregnant or lactating women.
- •Those expected to start/stop any treatments which might impact bowel function other than opioids throughout the study.
结局指标
主要结局
To compare the effectiveness of polyethylene glycol and bisacodyl in preventing opioid induced constipation in cancer patients initiating morphine therapy. The primary endpoint is the incidence of opioid induced constipation, as assessed by revised victoria bowel performance scale.
时间窗: at baseline, day 15, day 30, 3 month
次要结局
- To compare the incidence of adverse effects (eg. cramping, bloating, electrolyte imbalance) associated with polyethylene glycol & bisacodyl use.(day 15, day 30 & at 3 month)
- To assess the impact of treatment on quality of life, including any modifications in opioid use due to constipation-related discomfort.(day 15, day 30 & at 3 month)
研究者
Dr Sanjay Meena
Dr B.R.A.I.R.C.H. AIIMS, NEW DELHI