Clinical trial NCT00444093: 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 -
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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diarrhea
Enteritis
Cancer
Keywords: radiation therapy
diarrhea
enteritis
supportive therapy
therapy associated diarrhea
therapy associated enteritis
radiation therapy of the small pelvis
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
Collaborators: name: Maros Arznei GmbH
First posted: 2007-03-07
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.


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

Primary outcomes:
measure: Treatment Efficacy
timeFrame: 90 days
Secondary outcomes:
measure: Quality of life EORTC-QLQ C30
timeFrame: 90 days
measure: Diarrhea Assessment
timeFrame: 90 days
Other outcomes:
Locations:
Study officials:
affiliation: center of radiology, departement of radiation therapy, clinical center Giessen and Marburg
name: Michael Bieker, MD
role: PRINCIPAL_INVESTIGATOR
References: