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 -
Conditions
Diarrhea - Enteritis - Cancer
Conditions: official terms
Diarrhea - Enteritis
Conditions: Keywords
radiation therapy, diarrhea, enteritis, supportive therapy, therapy associated diarrhea, therapy associated enteritis, radiation therapy of the small pelvis
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Intervention
Name: Tinctura opii
Type: Drug
Overall Status
Not yet recruiting
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.
Criteria for eligibility
Healthy Volunteers:
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Location
Start Date
September 2007
Sponsors
Philipps University Marburg Medical Center
Source
Philipps University Marburg Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page