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 - (Loop)
Status and phase
Terminated
Phase 3
Conditions
Enteritis
Diarrhea
Cancer
Treatments
Drug: Opii normata treatment
Drug: Loperamid Treatment
Details and patient eligibility
About
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.
Enrollment
1 patient
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
1 participants in 2 patient groups
Opii normata treatment
Experimental group
Description:
Treamtment with opii normata in case of diarrhea
Treatment:
Drug: Opii normata treatment
Loperamid Treatment
Experimental group
Description:
Treatment with Loperamid in case of diarrhea
Treatment:
Drug: Loperamid Treatment
Trial contacts and locations
0
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Data sourced from clinicaltrials.gov
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