Diarrhea | 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 -
Diarrhea research study
What is the primary objective of this study?
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 is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: September 2007
Phase: Phase 3
Primary Outcome: 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.
Secondary Outcome: Scores from the EORTC-QLQ-C30
Study sponsors, principal investigator, and references
Principal Investigator: Michael Bieker, MD
Lead Sponsor: Philipps University Marburg Medical Center
Collaborator: Maros Arzneimittel GmbH