Immunity Factors in Cancer Colon PatientstumorimmunityNCT04518579
Epidural-inhalational Versus Epidural-intravenous Anaesthesia on Anti-tumor Immunity in Patients With Cancer Colon
A study testing thoracic epidural in people with Immunity Factors in Cancer Colon Patients, run by South Egypt Cancer Institute at 1 site in Egypt.
Trial 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 . Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Immunity Factors in Cancer Colon Patients
- What is being tested?
- thoracic epidural
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2018to 1 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20-70 yrs.
- ASA class I and II
- Elective open surgery for non-metastatic cancer colon stage I,II
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Epidural-inhalational Versus Epidural-intravenous Anaesthesia on Anti-tumor Immunity in Patients Undergoing Open Surgery for Cancer Colon
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.
- Being tested
- thoracic epidural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thoracic epiduralProcedure or surgery
Also called thoracic epidural catheter
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
| Study group | Role | What they receive |
|---|---|---|
| Group (EP) | Active comparator | Group (EP) received epidural (fentanyl and bupivacaine) - propofol based anesthetic technique and postoperative analgesia through patient controlled analgesia device (PCA) Receives: Procedure: thoracic epidural |
| Group (EH) | Active comparator | Group (EH) received epidural (fentanyl and bupivacaine)- inhalational based anesthetic technique and postoperative analgesia through patient controlled analgesia device (PCA) Receives: Procedure: thoracic epidural |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: preoperative and Day 1 postoperatively
Secondary outcomes (1)
change in pain intensity
pain intensity measured by Visual analogue scale from 0 to 10 where 0 no pain and 10 is sever pain
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start15 Apr 2018
- Primary completion1 Jun 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunity Factors in Cancer Colon PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Egypt Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahaa Gamal, South Egypt Cancer Institute
- Investigators
- samy ab amr, professor, Study chair, dean of SECI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04518579
- Sponsor's protocol ID
- 375
- Acronym
- tumorimmunity
- Status last verified
- Aug 2020
- First submitted
- 9 Aug 2020
- Last updated
- 21 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Epidural-inhalational Versus Epidural-intravenous Anaesthesia on Anti-tumor Immunity in Patients Undergoing Open Surgery for Cancer Colon
- ClinicalTrials.gov ID
- NCT04518579
- Acronym / sponsor ID
- tumorimmunity / 375
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- South Egypt Cancer InstituteUniversity, hospital or other
- Study start
- 15 Apr 2018 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 19 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Group (EP) | Active comparator | Procedure: thoracic epiduralGroup (EP) received epidural (fentanyl and bupivacaine) - propofol based anesthetic technique and postoperative analgesia through patient controlled analgesia device (PCA) |
| Group (EH) | Active comparator | Procedure: thoracic epiduralGroup (EH) received epidural (fentanyl and bupivacaine)- inhalational based anesthetic technique and postoperative analgesia through patient controlled analgesia device (PCA) |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 20-70 yrs.
- ASA class I and II
- Elective open surgery for non-metastatic cancer colon stage I,II
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thoracic epiduralAlso: thoracic epidural catheterundergo 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 | Procedure or surgery | Group (EH), Group (EP) |
Primary outcome
anti tumour immunity
Time frame: preoperative and Day 1 postoperatively
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
1 secondary outcome
change in pain intensity
Time frame: 24 hours postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
samy ab amr, professor study chair
dean of SECI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing thoracic epidural in people with Immunity Factors in Cancer Colon Patients, run by South Egypt Cancer Institute at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anti tumour immunity (time frame: preoperative and Day 1 postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2020.