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

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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

- 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