|
|
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 -
Basic Trial Information Trial Description Summary Eligibility Criteria Trial Contact Information
Basic Trial Information
|
Phase
|
|
|
|
Type
|
|
|
|
Status
|
|
|
|
Age
|
|
|
|
Sponsor
|
|
|
|
Protocol IDs
|
|
|
|
Phase III
|
|
|
|
Supportive care, Treatment
|
|
|
|
Approved-not yet active
|
|
|
|
18 and over
|
|
|
|
Other
|
|
|
|
2006-002948-28 KKS-73-05, NCT00444093
|
|
|
Trial Description
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. Eligibility Criteria Inclusion Criteria: - 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.
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
- Hypersensitivity to components of loperamide or tincture of opium
- 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
- Organisational problems or circumstances which prevent a complete collection of required data
- Participation in a clinical trial within the last 30 days before involvement
- Participation in an other clinical trial at the same time
Trial Contact Information
Trial Lead Organizations/Sponsors Universitaetsklinikum Giessen und Marburg GmbH - Marburg Maros Arzneimittel GmbH
Michael Bieker, MD | | Principal Investigator |
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00444093 Information obtained from ClinicalTrials.gov on February 27, 2008 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov. Back to Top |
|