Influence of Opioid Analgesia on Circulating Tumor Cells in Open Colorectal Cancer Surgery (POACC-1)

December 6, 2023 updated by: The Institute of Molecular and Translational Medicine, Czech Republic

Influence of Peri-operative Opioid Analgesia on Circulating Tumor Cells in Patients Undergoing Open Colorectal Cancer Surgery - Multi-center, Randomized Clinical Trial

To compare the effects of three types of perioperative analgesia on the number of circulating tumor cells following radical colorectal cancer surgery. To find correlations with other perioperative factors and clinical/pathological disease characteristics.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

125

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Ostrava, Czechia, 708 52
        • University Hospital Ostrava
      • Prague, Czechia, 12808
        • General University Hospital
    • Jihomoravsky Kraj
      • Zlin, Jihomoravsky Kraj, Czechia, 76275
        • T. Bata Regional Hospital Zlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients undergoing open radical surgery for colorectal cancer
  • age over 18 years
  • signed informed consent

Exclusion Criteria:

  • intolerance of the study drugs
  • history of CRC surgery
  • neoadjuvant therapy
  • contraindications to epidural analgesia
  • other malignancy not in permanent remission
  • chronic opioid medication or opioid administration within 7 days preoperatively
  • immunosuppressive or corticosteroid therapy
  • surgery within 30 days preoperatively (except minor)
  • chronic or acute infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Morphine
Morphine-based perioperative analgesia
Drug: Morphine
Morphine intravenous
Active Comparator: Piritramid
Piritramid-based perioperative analgesia
Drug: Piritramid
Piritramid intravenous
Active Comparator: Epidural
Perioperative epidural analgesia containing an opioid
Drug: Epidural
Perioperative epidural analgesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in number of circulating tumor cells prior to surgery to 2 - 4 weeks after surgery
Time Frame: 1 - 3 days before surgery to 4 weeks after surgery
Baseline number of circulating tumor cells will be recorded prior to surgery in a venous blood sample. Number of circulating tumor cells will be measured 2 - 4 weeks after surgery in a venous blood sample. These two values will be compared.
1 - 3 days before surgery to 4 weeks after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain assessment
Time Frame: 3 days postoperatively
Pain intensity assessed using Numerical Rating Scale (0-10)
3 days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Institute of Molecular and Translational Medicine, Czech Republic

Collaborators

University Hospital Ostrava
Tomas Bata Hospital, Czech Republic
General University Hospital, Prague
Hospital Novy Jicin

Investigators

  • Principal Investigator: Marian Hajduch, MD PhD, Institute of Molecular and Translational Medicine, Palacky University, Olomouc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2019

Primary Completion (Actual)

November 1, 2023

Study Completion (Actual)

December 6, 2023

Study Registration Dates

First Submitted

October 3, 2018

First Submitted That Met QC Criteria

October 7, 2018

First Posted (Actual)

October 9, 2018

Study Record Updates

Last Update Posted (Actual)

December 7, 2023

Last Update Submitted That Met QC Criteria

December 6, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POACC-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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