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 -

• Status: Terminated
• Trial end date: 2008-02-29
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Philipps University Marburg Medical Center
• Collaborator: Maros Arzneimittel GmbH
• Treatments: Antidiarrheals; Loperamide

Criteria

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