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
- 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.
- Pregnant patients or patients in lactation period.
- Severe dysfunction of liver or kidneys
- Injury or illness of brain e.g. increased intracranial pressure, cerebral
- 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
- Dysfunctional draining of biliary area, biliary colics.
- Concomitant or earlier addiction of alcohol or opiates
- Severe heart disease
- Acute hepatic porphyria
- Cor pulmonale
- Morbus Addison
- Severe hypothyroidism
- Organisational problems or circumstances which prevent a complete collection of
- Artificial anus
- Participation in a clinical trial within the last 30 days before involvement
- Participation in an other clinical trial at the same time