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)
Primary Purpose
Diarrhea, Enteritis, Cancer
Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Opii normata treatment
Loperamid Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Diarrhea focused on measuring radiation therapy, diarrhea, enteritis, supportive therapy, therapy associated diarrhea, therapy associated enteritis, radiation therapy of the small pelvis
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Opii normata treatment
Loperamid Treatment
Arm Description
Treamtment with opii normata in case of diarrhea
Treatment with Loperamid in case of diarrhea
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Quality of life EORTC-QLQ C30
Quality of life will be assessed with the EORTC-QLQ C30 questionnaire
Diarrhea Assessment
The quality and quantity of diarrhea will be assessed with a questionnaire
Full Information
NCT ID
NCT00444093
First Posted
March 6, 2007
Last Updated
May 9, 2023
Sponsor
Philipps University Marburg Medical Center
Collaborators
Maros Arznei GmbH
1. Study Identification
Unique Protocol Identification Number
NCT00444093
Brief 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 -
Acronym
Loop
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Terminated
Why Stopped
bad recruitment
Study Start Date
March 5, 2007 (Actual)
Primary Completion Date
February 29, 2008 (Actual)
Study Completion Date
February 29, 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philipps University Marburg Medical Center
Collaborators
Maros Arznei GmbH
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea, Enteritis, Cancer
Keywords
radiation therapy, diarrhea, enteritis, supportive therapy, therapy associated diarrhea, therapy associated enteritis, radiation therapy of the small pelvis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Comparision between treatment with Tinctura Opii normata and Loperamid in patients with therapy-associated diarrhea during radiaton therapy of small pelvis
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Opii normata treatment
Arm Type
Experimental
Arm Description
Treamtment with opii normata in case of diarrhea
Arm Title
Loperamid Treatment
Arm Type
Experimental
Arm Description
Treatment with Loperamid in case of diarrhea
Intervention Type
Drug
Intervention Name(s)
Opii normata treatment
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Loperamid Treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Treatment Efficacy
Description
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.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Quality of life EORTC-QLQ C30
Description
Quality of life will be assessed with the EORTC-QLQ C30 questionnaire
Time Frame
90 days
Title
Diarrhea Assessment
Description
The quality and quantity of diarrhea will be assessed with a questionnaire
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Bieker, MD
Organizational Affiliation
center of radiology, departement of radiation therapy, clinical center Giessen and Marburg
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
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 -
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