Official Title: “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”

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.

Study Type: Interventional

Study Design: Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Tinctura opii

Primary Measures

• 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.
• Should diarrhoea of grade > 2 occur despite the respective drug treatment, the corresponding medicament is assessed as inefficacious in that case.

Secondary Measures

• Scores from the EORTC-QLQ-C30
• Body composition data (BMI, proportions of fat and water

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Lead Sponsor: Philipps University Marburg Medical Center

Overall Clinical Trial Officials and Contacts

Michael Bieker, MD Principal Investigator center of radiology, departement of radiation therapy, clinical center Giessen and Marburg  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00444093

Study ID Number: 2006-002948-28

ClinicalTrials.gov Identifier: NCT00444093

Health Authority: Germany: Federal Institute for Drugs and Medical Devices