Prospective Randomized Open Label Study of the Treatment of Therapy-associated Diarrhea During Pe… (NCT00444093) | Clinical Trial Compass
TerminatedPhase 3
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 -
Stopped: bad recruitment
1 participantsStarted 2007-03-05
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 clin…