Clinical trial · Interventional
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 -
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): bad recruitment
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Diarrhea | — | UNRESOLVED | — |
| Enteritis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Loperamid Treatment | Drug | — | UNRESOLVED |
| Opii normata treatment | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Opii normata treatment
- description
- Treamtment with opii normata in case of diarrhea
- interventionNames
- Drug: Opii normata treatment
- type
- EXPERIMENTAL
- label
- Loperamid Treatment
- description
- Treatment with Loperamid in case of diarrhea
- interventionNames
- Drug: Loperamid Treatment
Primary outcomes (1)
- measure
- Treatment Efficacy
- timeFrame
- 90 days
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available