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)

May 9, 2023 updated by: Philipps University Marburg Medical Center

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 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.
90 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006-002948-28
  • KKS-73-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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