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 -

Phase 3

Terminated

• Conditions: Diarrhea; Enteritis; Cancer
• Interventions: Drug: Opii normata treatment; Drug: Loperamid Treatment

• Registration Number: NCT00444093
• Lead Sponsor: Philipps University Marburg Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-05
• Study First Submitted: 2007-03-06
• Study First Submitted QC: 2007-03-06
• Study First Posted: 2007-03-07
• Primary Completion: 2008-02-29
• Study Completion: 2008-02-29
• Status Verified: 2018-04
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Opii normata treatment	Opii normata treatment	Treamtment with opii normata in case of diarrhea
Loperamid Treatment	Loperamid Treatment	Treatment with Loperamid in case of diarrhea

Primary Outcome Measures

Name	Time	Method
Treatment Efficacy	90 days	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.

Secondary Outcome Measures

Name	Time	Method
Diarrhea Assessment	90 days	The quality and quantity of diarrhea will be assessed with a questionnaire
Quality of life EORTC-QLQ C30	90 days	Quality of life will be assessed with the EORTC-QLQ C30 questionnaire