Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT00444093
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00444093
Study Brief:
Protocol Section:
NCT00444093