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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 - (Loop)

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ClinicalTrials.gov Identifier: NCT00444093
Recruitment Status : Terminated (bad recruitment)
First Posted : March 7, 2007
Last Update Posted : April 12, 2018
Sponsor:
Collaborator:
Maros Arzneimittel GmbH
Information provided by (Responsible Party):
Philipps University Marburg Medical Center

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.

Condition or disease Intervention/treatment Phase
Diarrhea Enteritis Cancer Drug: Opii normata treatment Drug: Loperamid Treatment Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Comparision between treatment with Tinctura Opii normata and Loperamid in patients with therapy-associated diarrhea during radiaton therapy of small pelvis
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 5, 2007
Actual Primary Completion Date : February 29, 2008
Actual Study Completion Date : February 29, 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Opii normata treatment
Treamtment with opii normata in case of diarrhea
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.

Experimental: Loperamid Treatment
Treatment with Loperamid in case of diarrhea
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.




Primary Outcome Measures :
  1. Treatment Efficacy [ Time Frame: 90 days ]
    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.


Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 90 days ]
    Quality of life will be assessed with the EORTC-QLQ C30 questionnaire

  2. Diarrhea Assessment [ Time Frame: 90 days ]
    The quality and quantity of diarrhea will be assessed with a questionnaire



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00444093


Sponsors and Collaborators
Philipps University Marburg Medical Center
Maros Arzneimittel GmbH
Investigators
Principal Investigator: Michael Bieker, MD center of radiology, departement of radiation therapy, clinical center Giessen and Marburg

Responsible Party: Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT00444093     History of Changes
Other Study ID Numbers: 2006-002948-28
KKS-73-05
First Posted: March 7, 2007    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018

Keywords provided by Philipps University Marburg Medical Center:
radiation therapy
diarrhea
enteritis
supportive therapy
therapy associated diarrhea
therapy associated enteritis
radiation therapy of the small pelvis

Additional relevant MeSH terms:
Diarrhea
Enteritis
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Loperamide
Antidiarrheals
Opium
Gastrointestinal Agents
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents