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)

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

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.

Study Overview

• Status: Terminated
• Conditions: Cancer; Diarrhea; Enteritis
• Intervention / Treatment: Drug: Opii normata treatment; Drug: Loperamid Treatment

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Opii normata treatment; Treamtment with opii normata in case of diarrhea	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.
Experimental: Loperamid Treatment; Treatment with Loperamid in case of diarrhea	Drug: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Philipps University Marburg Medical Center
• Collaborators: Maros Arznei GmbH
• Investigators: Principal Investigator: Michael Bieker, MD, center of radiology, departement of radiation therapy, clinical center Giessen and Marburg

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2007
• Primary Completion (Actual): February 29, 2008
• Study Completion (Actual): February 29, 2008

Study Registration Dates

• First Submitted: March 6, 2007
• First Submitted That Met QC Criteria: March 6, 2007
• First Posted (Estimate): March 7, 2007

Study Record Updates

• Last Update Posted (Estimate): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: diarrhea; radiation therapy; supportive therapy; enteritis; therapy associated diarrhea; therapy associated enteritis; radiation therapy of the small pelvis
• Additional Relevant MeSH Terms: Digestive System Diseases; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Diarrhea; Enteritis; Gastrointestinal Agents; Loperamide; Antidiarrheals
• Other Study ID Numbers: 2006-002948-28; KKS-73-05