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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)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2007 by Philipps University Marburg Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00444093
First Posted: March 7, 2007
Last Update Posted: September 3, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Maros Arzneimittel GmbH
Information provided by:
Philipps University Marburg Medical Center
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00444093     History of Changes
Other Study ID Numbers: 2006-002948-28
KKS-73-05
First Submitted: March 6, 2007
First Posted: March 7, 2007
Last Update Posted: September 3, 2007
Last Verified: August 2007

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

Additional relevant MeSH terms:
Diarrhea
Enteritis
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Loperamide
Antidiarrheals
Gastrointestinal Agents


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