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 -

Cancer Clinical Trial

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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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00444093
• Other study ID #: 2006-002948-28
• Secondary ID: KKS-73-05
• Status: Terminated
• Phase: Phase 3
• Start date: March 5, 2007
• Est. completion date: February 29, 2008

Study information

• Verified date: April 2018
• Source: Philipps University Marburg Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: February 29, 2008
• Est. primary completion date: February 29, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Diarrhea
• Enteritis

Intervention

Drug:
• Opii normata treatment
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.
• Loperamid Treatment
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Philipps University Marburg Medical Center	Maros Arznei GmbH

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	90 days
Secondary	Quality of life EORTC-QLQ C30	Quality of life will be assessed with the EORTC-QLQ C30 questionnaire	90 days
Secondary	Diarrhea Assessment	The quality and quantity of diarrhea will be assessed with a questionnaire	90 days