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 -

Study Overview
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Brief Summary
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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.

Official Title
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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
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Diarrhea, Enteritis, Cancer

Intervention / Treatment
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* Drug: Opii normata treatment
* Drug: Loperamid Treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Comparision between treatment with Tinctura Opii normata and Loperamid in patients with therapy-associated diarrhea during radiaton therapy of small pelvis
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Opii normata treatment<br>Treamtment with opii normata in case of diarrhea | Drug: Opii normata treatment<br>* After beginning of diarrhea grade 1: 5 drops tincture of opium three times a day After beginning of diarrhea grade 2: Intensive therapy with 15 drops tincture of opium three times a day.<br>|
| Experimental: Loperamid Treatment<br>Treatment with Loperamid in case of diarrhea | Drug: Loperamid Treatment<br>* All patients who receive as a result of randomisation loperamide After beginning of diarrhea grade 1: Initial 4mg and 2mg after any unformed stool. The maximum dose amounts to16mg per day. After beginning of diarrhea grade 2: Intensive therapy with 2mg loperamide every 2 h. The maximum dose amounts to 16mg per day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Efficacy | In this study efficacy of loperamide and tincture of opium is linked to the respective proportions of patients where diarrhoea of grade > 2 is successfully averted during (cancer) therapy. | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life EORTC-QLQ C30 | Quality of life will be assessed with the EORTC-QLQ C30 questionnaire | 90 days | 
| Diarrhea Assessment | The quality and quantity of diarrhea will be assessed with a questionnaire | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radiation therapy, diarrhea, enteritis, supportive therapy, therapy associated diarrhea, therapy associated enteritis, radiation therapy of the small pelvis