Prospective randomized monoinstitutional study of the treatment of therapy-associated diarrhea during percutaneous radiation therapy of the small pelvis. – Comparison of loperamide and tincture of opium - Loop- - Loop
- Conditions
- Therapy-associated diarrhea during radiaton therapy of small pelvis (including enteritis as a result of radiation therapy and enteritis as a result of radiation- and chemotherapy).MedDRA version: 8.1Level: LLTClassification code 10012735Term: Diarrhoea
- Registration Number
- EUCTR2006-002948-28-DE
- Lead Sponsor
- MAROS Arzneimittel GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
•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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•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
•Epilepsy
•Hypersensitivity to components of loperamide or tincture of opium
•Ileus
•Toxic megacolon
•Pseudmembraneous colitis/ antibiotic-associated colitis
•Diarrhea associated with fever and bloody stools
•Acute increase of colitis ulcerosa 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 hypothyreoidism
•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 inclusion
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method