跳至主要内容
临床试验/CTRI/2025/09/094485
CTRI/2025/09/094485尚未招募Phase 3 4

Dexamethasone and metoclopramide in the management of patients with inoperable partial malignant bowel obstruction: A prospective, single-arm interventional multicentric trial.

Cancer Institute WIA6 个研究点 分布在 1 个国家入组 67 人开始时间: 2025年10月15日最近更新:
适应症
相关药物

试验速览

阶段
Phase 3 4
状态
尚未招募
入组人数
67
试验地点
6
主要终点
To assess the reduction in vomiting among patients with partial MBO who have received metoclopramide and dexamethasone.

研究概览

简要总结

Malignant bowel obstruction (MBO) is a serious complication in patients with ovarian and gastrointestinal malignancies with an incidence of 10-51percent. The patients suffer from a poor quality of life due to an increased symptoms such as pain, nausea and vomiting, and constipation. Further, the intolerance to orals adds to the necessity of   hospitalization. In the setting of an inoperable bowel obstruction, not amenable to stenting, medical management remains the only option.

Octreotide is among the drugs frequently used in the medical management of MBO, by virtue of its ability to reduce gut wall edema and gastric and pancreatic secretions. However, a double-blind, placebo controlled, RCT involving 87 patients did not demonstrate a statistically significant reduction in the number of days free from vomiting despite addition of octreotide. Dexamethasone and metoclopramide are two other drugs which have been consistently used in partial bowel obstruction and found to relieve pain, nausea, vomiting, and improve motility. While dexamethasone has anti-inflammatory effects that reduce gut wall edema, it is also a centrally acting antiemetic. Metoclopramide is a prokinetic with antiemetic properties. NCCN recommends both drugs in the management of patients with partial IMBO. A recent study among patients with partial IMBO, supports the safety and efficacy of triple therapy with dexamethasone, metoclopramide and octreotide in reducing pain, nausea, constipation and resumption of oral intake. However, the sample size in this study was 15 patients and further studies are needed to confirm the findings. A retrospective cohort study examining the effect of the triple therapy on rate of de-obstruction was not significantly different from patients who did not receive all 3 drugs. While guidelines recommend the use of octreotide as an antiemetic, the evidence is not strong and its cost high in developing countries precluding its use in all settings. Further, our unpublished data shows that the majority of the patients achieve symptom control with metoclopramide and dexamethasone without the addition of octreotide. Hence, this study aims to explore the efficacy of the combination of dexamethasone with metoclopramide in reducing symptoms among patients with inoperable partial, bowel obstruction.

研究设计

研究类型
干预性
分配方式
不适用
盲法
开放(无盲法)

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Age 18 yrs and above Diagnosis of partial bowel obstruction related to malignancy with failure to respond, at 48 hours, to conservative measures such as bowel rest, implemented by nil per os, IV hydration, nasogastric tube NGT insertion based on patient preference and pantoprazole 40 mg IV OD.
  • Radiological evidence of partial bowel obstruction with a CT abdomen and pelvis performed within 48-72 hours of the episode or if older imaging shows evidence of partial obstruction done less than a month ago.
  • Partial versus complete bowel obstruction will be determined based on the definition that partial bowel obstruction indicates that some fluid or gas passes beyond the site of obstruction or transition point.
  • Inoperable malignant bowel obstruction based on surgical consult and not amenable to stenting Not receiving active cancer directed therapy currently or patients who are on best supportive care.

排除标准

  • Patients with evidence of complete bowel obstruction on radiological imaging Steroid equivalent of dexamethasone 8 mg per day in the 7d prior to enrollment History of QT prolongation of QTc more than 500 ms on screening ECG History of tardive dyskinesia or dystonia Actively taking antipsychotic medications History of seizures in 12 months prior to enrollment or taking maintenance anti-epileptic therapy.

结局指标

主要结局

To assess the reduction in vomiting among patients with partial MBO who have received metoclopramide and dexamethasone.

时间窗: Baseline, 72 hours, 1 month, 3 months and 6 months

次要结局

  • Pain and nausea score at baseline and at the end of 72 hours using revised Edmonton symptom assessment scale (rESAS).(2. For the outcome of time to de-obstruction: Time since admission to first signal of resolution of bowel obstruction, where de-obstruction is defined as:)

研究者

申办方类型
Research institution and hospital
责任方
主要研究者
主要研究者

Meenakshi V Venketeswaran

Cancer Institute (WIA) ,Adyar, Chennai

研究点 (6)

Loading locations...

标识符

CTRI 编号
CTRI/2025/09/094485

日期

最近更新
(去年)