Efficacy of Hyaluronic Acid in Prevention of Acute Radiation Proctitis: Multi-center, Double-blind, Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Time (in days) to occurrence of Acute Radiation Proctitis
研究概览
简要总结
A randomized placebo-controlled clinical trial to evaluate efficacy of hyaluronic acid in prevention of acute radiation proctitis among oncology patient population especially who are diagnosed with abdomeno-pelvic tumors and subsequently required radiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients diagnosed with pelvic or gastrointestinal malignancies (tumors in uterus, cervix, prostate, seminal vesicles, kidney, colon, etc.),
- •All patients who required adjuvant or radical radiation therapy;
- •Age < 80 years;
- •Karnofsky Performance Status ≥ 60
排除标准
- •Patients were excluded if they had
- •gt; previous pelvic radiotherapy,
- •gt; inflammatory bowel disease or
- •gt; rectal issues (e.g., haemorrhoids).
- •Patients diagnosed with cancer rectum
研究组 & 干预措施
30 ml of Hyaluronic Acid (HA) enema will be given to the patients
All patients will be prospectively randomized into two groups; either the treatment (HA) group or the control group. In this study protocol, 30 ml of HA enema and 30 ml of placebo enema (identical to treatment group enema but without HA) will be given to the patients as they lie on their left side with their right knee pulled up to the chest.
干预措施: Hyaluronic Acid (Drug)
30 ml of placebo enema (identical to treatment group enema but without HA) will be given to patients
All patients will be prospectively randomized into two groups; either the treatment (HA) group or the control group. In this study protocol, 30 ml of HA enema and 30 ml of placebo enema (identical to treatment group enema but without HA) will be given to the patients as they lie on their left side with their right knee pulled up to the chest.
干预措施: Placebo (Other)
结局指标
主要结局
Time (in days) to occurrence of Acute Radiation Proctitis
时间窗: for each patient: time from the first day of radiation therapy for up to 3 months
次要结局
未报告次要终点
研究者
Samar Gamal El Sheikh
Clinical pharmacist at Al-Ahrar Oncology Center
Assiut University