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 - (Loop)
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ClinicalTrials.gov Identifier: NCT00444093
Verified August 2007 by Philipps University Marburg Medical Center. Recruitment status was: Not yet recruiting
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.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
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)
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 arteriosclerosis
Hypersensitivity to components of loperamide or tincture of opium