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 -

NCT ID: NCT00444093

Last Updated: 2023-05-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-05
• Study Completion Date: 2008-02-29

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.

Conditions

Diarrhea; Enteritis; Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Opii normata treatment

Treamtment with opii normata in case of diarrhea

Group Type: EXPERIMENTAL

Opii normata treatment

Intervention Type: DRUG

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

Treatment with Loperamid in case of diarrhea

Group Type: EXPERIMENTAL

Loperamid Treatment

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maros Arznei GmbH

UNKNOWN

Sponsor Role: collaborator

Philipps University Marburg

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Bieker, MD

Role: PRINCIPAL_INVESTIGATOR

center of radiology, departement of radiation therapy, clinical center Giessen and Marburg

Other Identifiers

KKS-73-05

Identifier Type: -

Identifier Source: secondary_id

2006-002948-28

Identifier Type: -

Identifier Source: org_study_id