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Epidural-inhalational Versus Epidural-intravenous Anaesthesia on Anti-tumor Immunity in Patients With Cancer Colon (tumorimmunity)

Primary Purpose

Immunity Factors in Cancer Colon Patients

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
thoracic epidural
Sponsored by
South Egypt Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Immunity Factors in Cancer Colon Patients

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 20-70 yrs.
  • ASA class I and II
  • Elective open surgery for non-metastatic cancer colon stage I,II

Exclusion Criteria:

  • Patient refusal
  • Known allergy to the study medications
  • Patients with compromised immune function ( associated blood diseases, immunosuppressive drugs, chemotherapeutic agents, corticosteroids)
  • Contraindications to epidural insertion e.g. infection at insertion site and coagulopathy

Sites / Locations

  • South Egypt Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group (EP)

Group (EH)

Arm Description

Group (EP) received epidural (fentanyl and bupivacaine) - propofol based anesthetic technique and postoperative analgesia through patient controlled analgesia device (PCA)

Group (EH) received epidural (fentanyl and bupivacaine)- inhalational based anesthetic technique and postoperative analgesia through patient controlled analgesia device (PCA)

Outcomes

Primary Outcome Measures

anti tumour immunity
Venous blood samples are withdrawn. Samples for measurement of percentage of expression of CD8,CD16 and CD56 will be collected in sodium heparin anticoagulant tubes and will be processed according to manufacturer's instructions,and samples for VEGF-C will be centrifuged at 4000 g. Thereafter, the serum will be stored at -22 C for future measurement

Secondary Outcome Measures

change in pain intensity
pain intensity measured by Visual analogue scale from 0 to 10 where 0 no pain and 10 is sever pain

Full Information

First Posted
August 9, 2020
Last Updated
August 19, 2020
Sponsor
South Egypt Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04518579
Brief Title
Epidural-inhalational Versus Epidural-intravenous Anaesthesia on Anti-tumor Immunity in Patients With Cancer Colon
Acronym
tumorimmunity
Official Title
Effect of Epidural-inhalational Versus Epidural-intravenous Anaesthesia on Anti-tumor Immunity in Patients Undergoing Open Surgery for Cancer Colon
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
April 15, 2018 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
August 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Egypt Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Surgery is the primary treatment for colon cancer. However, the rate of recurrence or metastasis in colon cancer can be as high as 30%, even in stages 1 and 2 . Most colon cancer-related deaths are caused by metastatic disease . Many patients with colon cancer harbour micrometastases and disseminated tumour cells at the time of surgery . Whether the micrometastases develop into clinically significant metastases depends on the immune system's ability to eradicate them.The aim of the study is to declare the effect of epidural-intravenous based anesthetic technique on anti-tumor immunity and in comparison to epidural inhalational based anesthetic technique in patients undergoing open surgical resection of colon cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immunity Factors in Cancer Colon Patients

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group (EP) received epidural - propofol based anesthetic technique and postoperative analgesia through patient controlled epidural analgesia and Group (EH) received epidural- inhalational based anesthetic technique and postoperative analgesia through patient controlled epidural analgesia
Masking
Participant
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group (EP)
Arm Type
Active Comparator
Arm Description
Group (EP) received epidural (fentanyl and bupivacaine) - propofol based anesthetic technique and postoperative analgesia through patient controlled analgesia device (PCA)
Arm Title
Group (EH)
Arm Type
Active Comparator
Arm Description
Group (EH) received epidural (fentanyl and bupivacaine)- inhalational based anesthetic technique and postoperative analgesia through patient controlled analgesia device (PCA)
Intervention Type
Procedure
Intervention Name(s)
thoracic epidural
Other Intervention Name(s)
thoracic epidural catheter
Intervention Description
undergo insertion of an epidural catheter, between T9 and T11 in patients undergoing left-sided resections and between T8 and T10 in patients undergoing right-sided resections
Primary Outcome Measure Information:
Title
anti tumour immunity
Description
Venous blood samples are withdrawn. Samples for measurement of percentage of expression of CD8,CD16 and CD56 will be collected in sodium heparin anticoagulant tubes and will be processed according to manufacturer's instructions,and samples for VEGF-C will be centrifuged at 4000 g. Thereafter, the serum will be stored at -22 C for future measurement
Time Frame
preoperative and Day 1 postoperatively
Secondary Outcome Measure Information:
Title
change in pain intensity
Description
pain intensity measured by Visual analogue scale from 0 to 10 where 0 no pain and 10 is sever pain
Time Frame
24 hours postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 20-70 yrs. ASA class I and II Elective open surgery for non-metastatic cancer colon stage I,II Exclusion Criteria: Patient refusal Known allergy to the study medications Patients with compromised immune function ( associated blood diseases, immunosuppressive drugs, chemotherapeutic agents, corticosteroids) Contraindications to epidural insertion e.g. infection at insertion site and coagulopathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
samy ab amr, professor
Organizational Affiliation
dean of SECI
Official's Role
Study Chair
Facility Information:
Facility Name
South Egypt Cancer Institute
City
Assuit
ZIP/Postal Code
71511
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Epidural-inhalational Versus Epidural-intravenous Anaesthesia on Anti-tumor Immunity in Patients With Cancer Colon

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