Prospective Randomized Open Label Study of the Treatment of Therapy-associated Diarrhea During Percutaneous Radiation Therapy of the Small Pelvis. - Comparison of Loperamide and Tincture of Opium
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 1
- 主要终点
- Treatment Efficacy
研究概览
简要总结
Therapy-associated diarrhea during radiation therapy of small pelvis (including enteritis as a result of radiation therapy and enteritis as a result of radiation- and chemotherapy) is a common problem in multimodal cancer therapy. We investigate the therapeutic effect of either loperamide or tinctura opii in therapy- associated diarrhea in patients who receive radiation therapy of the small pelvis with or without chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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 who will undergo a percutaneous radiation therapy in the area of the small pelvis. This includes patients with following malignancies: rectal carcinoma, prostate carcinoma, endometrial carcinoma, cervix carcinoma.
- •Diarrhea grade 1 and grade 2 (Classification NCI-CTCAE Version 3.0)
- •ECOG-Grade 0-2
- •Enlightenment and written declaration of consent to the participation.
排除标准
- •Pregnant patients or patients in lactation period.
- •Severe dysfunction of liver or kidneys
- •Injury or illness of brain e.g. increased intracranial pressure, cerebral arteriosclerosis
- •Hypersensitivity to components of loperamide or tincture of opium
- •Toxic megacolon
- •Pseudomembranous colitis/ antibiotic-associated colitis
- •Diarrhea associated with fever and bloody stools
- •Acute increase of colitis ulcerous or bacterial colitis caused by invasive pathogenes
- •Severe respiratory dysfunction or severely limited lung function e.g. bronchial asthma, bronchitis
- •Dysfunctional draining of biliary area, biliary colics.
- •Concomitant or earlier addiction of alcohol or opiates
- •Severe heart disease
- •Pheochromocytoma
- •Acute hepatic porphyria
- •Cor pulmonale
- •Morbus Addison
- •Severe hypothyroidism
- •Organisational problems or circumstances which prevent a complete collection of required data
- •Artificial anus
- •Participation in a clinical trial within the last 30 days before involvement
- •Participation in an other clinical trial at the same time
研究组 & 干预措施
Opii normata treatment
Treamtment with opii normata in case of diarrhea
干预措施: Opii normata treatment (Drug)
Loperamid Treatment
Treatment with Loperamid in case of diarrhea
干预措施: Loperamid Treatment (Drug)
结局指标
主要结局
Treatment Efficacy
时间窗: 90 days
In this study efficacy of loperamide and tincture of opium is linked to the respective proportions of patients where diarrhoea of grade \> 2 is successfully averted during (cancer) therapy.
次要结局
- Diarrhea Assessment(90 days)
- Quality of life EORTC-QLQ C30(90 days)