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

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ClinicalTrials.gov Identifier: NCT03700411
Recruitment Status : Recruiting
First Posted : October 9, 2018
Last Update Posted : March 12, 2019
Sponsor:
Collaborators:
General University Hospital, Prague
Tomas Bata Hospital, Czech Republic
University Hospital Ostrava
Hospital Novy Jicin
Information provided by (Responsible Party):
Marian Hajduch, M.D., Ph.D., The Institute of Molecular and Translational Medicine, Czech Republic

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Circulating Tumor Cell Drug: Morphine Drug: Piritramid Drug: Epidural Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Influence of Peri-operative Opioid Analgesia on Circulating Tumor Cells in Patients Undergoing Open Colorectal Cancer Surgery - Multi-center, Randomized Clinical Trial
Actual Study Start Date : January 7, 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change in number of circulating tumor cells prior to surgery to 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 4 weeks after surgery in a venous blood sample. These two values will be compared.


Secondary Outcome Measures :
  1. Pain assessment [ Time Frame: 3 days postoperatively ]
    Pain intensity assessed using Numerical Rating Scale (0-10)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03700411


Contacts
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Contact: Emil Berta, MD PhD 00420608801303 e.berta@email.cz
Contact: Josef Srovnal, MD PhD 00420585632111 srovnalj@upol.cz

Locations
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Czechia
T. Bata Regional Hospital Zlin Recruiting
Zlin, Jihomoravsky Kraj, Czechia, 76275
Contact: Tomas Gabrhelik, MD, PhD    +420577552280    Tomas.Gabrhelik@bnzlin.cz   
University Hospital Ostrava Recruiting
Ostrava, Czechia, 708 52
Contact: Jan Máca, MD PhD    ‭+420603728998‬      
General University Hospital Recruiting
Prague, Czechia, 12808
Contact: Pavel Michalek, MD PhD    ‭+420602776261‬      
Sponsors and Collaborators
The Institute of Molecular and Translational Medicine, Czech Republic
General University Hospital, Prague
Tomas Bata Hospital, Czech Republic
University Hospital Ostrava
Hospital Novy Jicin
Investigators
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Principal Investigator: Marian Hajduch, MD PhD Institute of Molecular and Translational Medicine, Palacky University, Olomouc

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Responsible Party: Marian Hajduch, M.D., Ph.D., Director, The Institute of Molecular and Translational Medicine, Czech Republic
ClinicalTrials.gov Identifier: NCT03700411     History of Changes
Other Study ID Numbers: POACC-1
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marian Hajduch, M.D., Ph.D., The Institute of Molecular and Translational Medicine, Czech Republic:
Perioperative analgesia
Colorectal Cancer
Circulating Tumor Cell
Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplastic Cells, Circulating
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Morphine
Pirinitramide
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents