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

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: Colorectal Cancer; Circulating Tumor Cell
• Intervention / Treatment: Drug: Morphine; Drug: Piritramid; Drug: Epidural

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Emil Berta, MD PhD; Phone Number: 00420608801303; Email: e.berta@email.cz
• Study Contact Backup: Name: Josef Srovnal, MD PhD; Phone Number: 00420585632111; Email: srovnalj@upol.cz

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

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

How is the study designed?

Design Details

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

Number of Arms

3

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	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	Pain intensity assessed using Numerical Rating Scale (0-10)	3 days postoperatively

Collaborators and Investigators

• 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

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: Colorectal Cancer; Perioperative analgesia; Circulating Tumor Cell
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplastic Processes; Neoplasm Metastasis; Colorectal Neoplasms; Neoplastic Cells, Circulating; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine; Pirinitramide
• 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