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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)

Primary Purpose

Diarrhea, Enteritis, Cancer

Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Opii normata treatment
Loperamid Treatment
Sponsored by
Philipps University Marburg Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diarrhea focused on measuring radiation therapy, diarrhea, enteritis, supportive therapy, therapy associated diarrhea, therapy associated enteritis, radiation therapy of the small pelvis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Opii normata treatment

    Loperamid Treatment

    Arm Description

    Treamtment with opii normata in case of diarrhea

    Treatment with Loperamid in case of diarrhea

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Quality of life EORTC-QLQ C30
    Quality of life will be assessed with the EORTC-QLQ C30 questionnaire
    Diarrhea Assessment
    The quality and quantity of diarrhea will be assessed with a questionnaire

    Full Information

    First Posted
    March 6, 2007
    Last Updated
    May 9, 2023
    Sponsor
    Philipps University Marburg Medical Center
    Collaborators
    Maros Arznei GmbH
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00444093
    Brief 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 -
    Acronym
    Loop
    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

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Terminated
    Why Stopped
    bad recruitment
    Study Start Date
    March 5, 2007 (Actual)
    Primary Completion Date
    February 29, 2008 (Actual)
    Study Completion Date
    February 29, 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Philipps University Marburg Medical Center
    Collaborators
    Maros Arznei GmbH

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diarrhea, Enteritis, Cancer
    Keywords
    radiation therapy, diarrhea, enteritis, supportive therapy, therapy associated diarrhea, therapy associated enteritis, radiation therapy of the small pelvis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    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)
    Allocation
    Randomized
    Enrollment
    1 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Opii normata treatment
    Arm Type
    Experimental
    Arm Description
    Treamtment with opii normata in case of diarrhea
    Arm Title
    Loperamid Treatment
    Arm Type
    Experimental
    Arm Description
    Treatment with Loperamid in case of diarrhea
    Intervention Type
    Drug
    Intervention Name(s)
    Opii normata treatment
    Intervention Description
    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
    Intervention Name(s)
    Loperamid Treatment
    Intervention Description
    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 Measure Information:
    Title
    Treatment Efficacy
    Description
    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.
    Time Frame
    90 days
    Secondary Outcome Measure Information:
    Title
    Quality of life EORTC-QLQ C30
    Description
    Quality of life will be assessed with the EORTC-QLQ C30 questionnaire
    Time Frame
    90 days
    Title
    Diarrhea Assessment
    Description
    The quality and quantity of diarrhea will be assessed with a questionnaire
    Time Frame
    90 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael Bieker, MD
    Organizational Affiliation
    center of radiology, departement of radiation therapy, clinical center Giessen and Marburg
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    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 -

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