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Diarrhea | 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 -

Diarrhea research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Diarrhea

Enteritis

Cancer

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Opii normata treatmentAfter 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.

Drug:Loperamid TreatmentAll 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Opii normata treatmentTreamtment with opii normata in case of diarrhea

Loperamid TreatmentTreatment with Loperamid in case of diarrhea

Study Status

Terminated

Start Date: March 5, 2007

Completed Date: February 29, 2008

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Treatment Efficacy

Secondary Outcome: Quality of life

Study sponsors, principal investigator, and references

Principal Investigator: Michael Bieker, MD

Lead Sponsor: Philipps University Marburg Medical Center

Collaborator: Maros Arzneimittel GmbH

More information:https://clinicaltrials.gov/show/NCT00444093

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