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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Diarrhea, Enteritis, Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

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.

Principal Investigator

Michael Bieker, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

2006-002948-28

NCT ID:

NCT00444093

Start Date:

September 2007

Completion Date:

Related Keywords:

  • Diarrhea
  • Enteritis
  • Cancer
  • radiation therapy
  • diarrhea
  • enteritis
  • supportive therapy
  • therapy associated diarrhea
  • therapy associated enteritis
  • radiation therapy of the small pelvis
  • Diarrhea
  • Enteritis

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