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Preventive Effect of Enoxaparin, Pentoxifylline and Ursodeoxycholic Acid to Radiation Induced Liver Toxicity

NCT01149304 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2017-11-20

No results posted yet for this study

Summary

To evaluate whether a combination regimen of pentoxifylline, ursodeoxycholic acid and enoxaparin provides a protective effect on the liver parenchyma after high dose rate (HDR) brachytherapy.

Conditions

  • Colorectal Cancer
  • Liver Metastases
  • Irradiation Damage
  • Radiation Induced Liver Disease

Interventions

DRUG

Pentoxifylline

Pentoxifylline is given for 8 weeks since the evening of the day of intervention with a dose of 400mg applied three times daily (morning, noon, evening).

DRUG

Ursodeoxycholic Acid

Ursodeoxycholic acid is administered for 8 weeks since the evening of the day of intervention. Dosage is 250mg given three times daily (morning, noon, evening).

DRUG

Enoxaparin

Enoxaparin with a dose of 40mg is injected subcutaneously once a day for 8 weeks since the evening of the day of intervention after the HDR-brachytherapy.

Sponsors & Collaborators

  • Sirtex Medical

    collaborator INDUSTRY

  • University of Magdeburg

    lead OTHER

Principal Investigators

  • Jens Ricke, MD · University of Magdeburg, Faculty for Medicine

  • Robert Damm, MD · University of Magdeburg, Faculty for Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2017-11-15

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01149304 on ClinicalTrials.gov