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

Sponsor

The Institute of Molecular and Translational Medicine, Czech Republic (Other)

Overall Status

Recruiting

CT.gov ID

NCT03700411

Collaborator

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

120

Enrollment

Locations

Arms

47.8

Anticipated Duration (Months)

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

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.

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

Study Design

Study Type:

Interventional

Anticipated 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 :

Jan 7, 2019

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in number of circulating tumor cells prior to surgery to 2 - 4 weeks after surgery [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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	T. Bata Regional Hospital Zlin	Zlin	Jihomoravsky Kraj	Czechia	76275
2	University Hospital Ostrava	Ostrava		Czechia	708 52
3	General University Hospital	Prague		Czechia	12808