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

Primary Purpose

Colorectal Cancer, Circulating Tumor Cell

Status
Recruiting
Phase
Phase 4
Locations
Czechia
Study Type
Interventional
Intervention
Morphine
Piritramid
Epidural
Sponsored by
The Institute of Molecular and Translational Medicine, Czech Republic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Perioperative analgesia, Colorectal Cancer, Circulating Tumor Cell

Eligibility Criteria

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

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

Sites / Locations

  • T. Bata Regional Hospital ZlinRecruiting
  • University Hospital OstravaRecruiting
  • General University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Morphine

Piritramid

Epidural

Arm Description

Morphine-based perioperative analgesia

Piritramid-based perioperative analgesia

Perioperative epidural analgesia containing an opioid

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Pain assessment
Pain intensity assessed using Numerical Rating Scale (0-10)

Full Information

First Posted
October 3, 2018
Last Updated
September 26, 2023
Sponsor
The Institute of Molecular and Translational Medicine, Czech Republic
Collaborators
General University Hospital, Prague, Tomas Bata Hospital, Czech Republic, University Hospital Ostrava, Hospital Novy Jicin
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1. Study Identification

Unique Protocol Identification Number
NCT03700411
Brief Title
Influence of Opioid Analgesia on Circulating Tumor Cells in Open Colorectal Cancer Surgery
Acronym
POACC-1
Official Title
Influence of Peri-operative Opioid Analgesia on Circulating Tumor Cells in Patients Undergoing Open Colorectal Cancer Surgery - Multi-center, Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 7, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Institute of Molecular and Translational Medicine, Czech Republic
Collaborators
General University Hospital, Prague, Tomas Bata Hospital, Czech Republic, University Hospital Ostrava, Hospital Novy Jicin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Circulating Tumor Cell
Keywords
Perioperative analgesia, Colorectal Cancer, Circulating Tumor Cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Morphine
Arm Type
Active Comparator
Arm Description
Morphine-based perioperative analgesia
Arm Title
Piritramid
Arm Type
Active Comparator
Arm Description
Piritramid-based perioperative analgesia
Arm Title
Epidural
Arm Type
Active Comparator
Arm Description
Perioperative epidural analgesia containing an opioid
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Description
Morphine intravenous
Intervention Type
Drug
Intervention Name(s)
Piritramid
Intervention Description
Piritramid intravenous
Intervention Type
Drug
Intervention Name(s)
Epidural
Intervention Description
Perioperative epidural analgesia
Primary Outcome Measure Information:
Title
Change in number of circulating tumor cells prior to surgery to 2 - 4 weeks after surgery
Description
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.
Time Frame
1 - 3 days before surgery to 4 weeks after surgery
Secondary Outcome Measure Information:
Title
Pain assessment
Description
Pain intensity assessed using Numerical Rating Scale (0-10)
Time Frame
3 days postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emil Berta, MD PhD
Phone
00420608801303
Email
e.berta@email.cz
First Name & Middle Initial & Last Name or Official Title & Degree
Josef Srovnal, MD PhD
Phone
00420585632111
Email
srovnalj@upol.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marian Hajduch, MD PhD
Organizational Affiliation
Institute of Molecular and Translational Medicine, Palacky University, Olomouc
Official's Role
Principal Investigator
Facility Information:
Facility Name
T. Bata Regional Hospital Zlin
City
Zlin
State/Province
Jihomoravsky Kraj
ZIP/Postal Code
76275
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tomas Gabrhelik, MD, PhD
Phone
+420577552280
Email
Tomas.Gabrhelik@bnzlin.cz
Facility Name
University Hospital Ostrava
City
Ostrava
ZIP/Postal Code
708 52
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Máca, MD PhD
Phone
‭+420603728998‬
Facility Name
General University Hospital
City
Prague
ZIP/Postal Code
12808
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pavel Michalek, MD PhD
Phone
‭+420602776261‬

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Influence of Opioid Analgesia on Circulating Tumor Cells in Open Colorectal Cancer Surgery

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