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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00444093
Other study ID # 2006-002948-28
Secondary ID KKS-73-05
Status Terminated
Phase Phase 3
First received
Last updated
Start date March 5, 2007
Est. completion date February 29, 2008

Study information

Verified date April 2018
Source Philipps University Marburg Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 1
Est. completion date February 29, 2008
Est. primary completion date February 29, 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Opii normata treatment
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.
Loperamid Treatment
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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Philipps University Marburg Medical Center Maros Arznei GmbH

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Quality of life EORTC-QLQ C30 Quality of life will be assessed with the EORTC-QLQ C30 questionnaire 90 days
Secondary Diarrhea Assessment The quality and quantity of diarrhea will be assessed with a questionnaire 90 days
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