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 -

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

Sponsors

Lead Sponsor: Philipps University Marburg Medical Center

Collaborator: Maros Arzneimittel GmbH

Source Philipps University Marburg Medical Center
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.

Overall Status Terminated
Start Date 2007-03-05
Completion Date 2008-02-29
Primary Completion Date 2008-02-29
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Treatment Efficacy 90 days
Secondary Outcome
Measure Time Frame
Quality of life 90 days
Diarrhea Assessment 90 days
Enrollment 1
Condition
Intervention

Intervention Type: Drug

Intervention Name: Opii normata treatment

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.

Arm Group Label: Opii normata treatment

Intervention Type: Drug

Intervention Name: Loperamid Treatment

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.

Arm Group Label: Loperamid Treatment

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Michael Bieker, MD Principal Investigator center of radiology, departement of radiation therapy, clinical center Giessen and Marburg
Verification Date

2018-04-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Opii normata treatment

Type: Experimental

Description: Treamtment with opii normata in case of diarrhea

Label: Loperamid Treatment

Type: Experimental

Description: Treatment with Loperamid in case of diarrhea

Acronym Loop
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Comparision between treatment with Tinctura Opii normata and Loperamid in patients with therapy-associated diarrhea during radiaton therapy of small pelvis

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov

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