Efficacy of Ondansetron in the Treatment of Low Anterior Resection Syndrome (LARS): a Multi-centre, Randomized, Double Blind, Placebo-controlled Crossover Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Change in LARS score
研究概览
简要总结
Patients will be randomized (1:1 ratio) to receive either 4 weeks of Ondansetron followed by 4 weeks of placebo (O-P sequence) or 4 weeks of placebo followed by 4 weeks of Ondansetron (P-O sequence). It will be one week of washout between the two treatments.
During the treatment questionnaires will be completed by the patients to evaluate the efficacy of the study treatment and the quality of live.
详细描述
This is a multi-centre randomized, double-blind, placebo-controlled, cross-over study aimed at testing the efficacy of Ondansetron in the low anterior resection syndrome (LARS) occurring as a consequence of surgery for rectal cancer.
Patients will be randomized (1:1 ratio) to receive either 4 weeks of Ondansetron followed by 4 weeks of placebo (O-P sequence) or 4 weeks of placebo followed by 4 weeks of Ondansetron (P-O sequence). Neither the investigator nor the patient will be aware of the sequence (O-P or P-O) assigned to the patient. One week will elapse between the end of the first treatment and start of the second treatment.
The hypothesis to be tested is that 4 weeks of oral Ondansetron at the dose of 4mg BID induce a variation of the LARS Score at least 7 points (20%) greater than the variation occurring after 4 weeks of placebo.
The sample size calculated for the primary analysis is 38 evaluable patients. Considering an expected attrition rate of about 20%, it is expected to enrol approximately 46 patients in total.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Patients willing and able to comply with the study procedures
- •Female patients of childbearing potential must agree to use a reliable method of contraception
- •Written informed consent Patients who have undergone low anterior resection (LAR) for rectal cancer in the last 2 years provided that at least 4 weeks have elapsed since recanalization and 4 weeks have elapsed since any chemo- and/or radiotherapy
- •Presence of functioning anastomosis
- •Presence of significant LARS symptoms assessed by LARS Score
排除标准
- •Known hypersensitivity or allergy to Ondansetron
- •Previous Ondansetron antiemetic therapy completed less than 4 weeks before study entry
- •Antitumor chemotherapy or radiotherapy completed less than 4 weeks before study entry
- •Congenital long Q-T syndrome
- •Ongoing treatment with drugs causing prolongation of the Q-T interval
- •Uncorrected hypokalemia or hypomagnesemia
- •Women who are pregnant or breast feeding or are willing to become pregnant during the study
- •Clinically significant concomitant disease states or anastomotic complications which could impair the ability of the patient to participate in the trial
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
研究组 & 干预措施
P-O sequence
Patients will receive oral placebo for 28 days followed by Ondansetron 4mg BD for 28 days. It will be one week of washout between the two treatments.
干预措施: Placebo (Drug)
O-P sequence
Patients will receive of oral Ondansetron 4mg BD for 28 days followed by 28 days of placebo. It will be one week of washout between the two treatments.
干预措施: Ondansetron 4 MG (Drug)
O-P sequence
Patients will receive of oral Ondansetron 4mg BD for 28 days followed by 28 days of placebo. It will be one week of washout between the two treatments.
干预措施: Placebo (Drug)
P-O sequence
Patients will receive oral placebo for 28 days followed by Ondansetron 4mg BD for 28 days. It will be one week of washout between the two treatments.
干预措施: Ondansetron 4 MG (Drug)
结局指标
主要结局
Change in LARS score
时间窗: 10 wks
The primary outcome is the change in LARS Score assessed before and after Ondansetron and placebo treatment
次要结局
- Vaizey (St. Mark's) score(10 wks)
- Irritable Bowel Syndrome-Quality of Life(10 wks)