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 - - Full Text View

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)

This study is not yet open for participant recruitment.

Verified by Philipps University Marburg Medical Center, August 2007

Sponsors and Collaborators:	Philipps University Marburg Medical Center Maros Arzneimittel GmbH
Information provided by:	Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier:	NCT00444093

Purpose

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.

Condition	Intervention	Phase
Diarrhea Enteritis Cancer	Drug: Tinctura opii	Phase III

MedlinePlus related topics: Cancer Diarrhea

Drug Information available for: Loperamide Loperamide hydrochloride Opium tincture

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by Philipps University Marburg Medical Center:

Primary Outcome Measures:

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.
Should diarrhoea of grade > 2 occur despite the respective drug treatment, the corresponding medicament is assessed as inefficacious in that case.

Secondary Outcome Measures:

Scores from the EORTC-QLQ-C30
Body composition data (BMI, proportions of fat and water

Estimated Enrollment:	200
Study Start Date:	September 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00444093

Sponsors and Collaborators

Philipps University Marburg Medical Center

Maros Arzneimittel GmbH

Investigators

Principal Investigator:

Michael Bieker, MD

center of radiology, departement of radiation therapy, clinical center Giessen and Marburg

More Information

Study ID Numbers:	2006-002948-28, KKS-73-05
Study First Received:	March 6, 2007
Last Updated:	August 31, 2007
ClinicalTrials.gov Identifier:	NCT00444093
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Philipps University Marburg Medical Center:

radiation therapy
diarrhea
enteritis
supportive therapy

therapy associated diarrhea
therapy associated enteritis
radiation therapy of the small pelvis

Study placed in the following topic categories:

Signs and Symptoms
Digestive System Diseases
Diarrhea
Signs and Symptoms, Digestive
Gastrointestinal Diseases

Enteritis
Loperamide
Intestinal Diseases
Gastroenteritis

ClinicalTrials.gov processed this record on January 16, 2009