Colon CancerPhase 4NCT02314871
Effects of Different Types of Perioperative Analgesia on Minimal Residual Disease Development After Colon Cancer Surgery
A Phase 4 study testing Epidural analgesia, Piritramide and Morphine in people with Colon Cancer and Minimal Residual Disease, run by The Institute of Molecular and Translational Medicine, Czech Republic at 2 sites in Czechia.
Trial summary
The aim of this study is to compare the effects of three types of perioperative analgesia on the number of circulating cancer cells (representing minimal residual disease) following radical colon cancer surgery. Patients will be randomized into one of three groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer, Minimal Residual Disease
- What is being tested?
- Epidural analgesia, Piritramide and Morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesCzechia
- Study dates
- Jan 2015to Mar 2019
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing open radical surgery for colon cancer (without known extension beyond colon)
- Age over 18 years
- Written informed consent
Who cannot join
- Allergy or intolerance of morphine, piritramide, marcaine, sufentanil or volatile anesthetics
- History of colon cancer resection
- Other cancer present (apart from those in complete long-term remission for minimum 6 months)
- Chronic opioid medication and/or opioid administration 7 days or less prior to surgery
- Any contraindication to thoracic epidural anesthesia/analgesia
- Systemic therapy with immunosuppressive drugs or corticoids (apart from topical and inhalational)
- Any surgery within the last 30 days (apart from minor day-case procedures)  - Chronic or acute infectious disease, particularly hepatitis, AIDS, tuberculosis
Trial locations and contacts
2 sites in 1 country.
Czechia2 sites
Brno University Hospital
Brno, South Moravian, 62500
T. Bata Regional Hospital Zlin
Zlin, South Moravian, 76275
About this study
The aim of this study is to compare the effects of three types of perioperative analgesia on the number of circulating cancer cells (representing minimal residual disease) following radical colon cancer surgery. Patients will be randomized into one of three groups. The intervention group will receive combined regional and general anesthesia during surgery and postoperative epidural analgesia. The two control groups will receive balanced general anesthesia and either morphine-based or piritramide-based postoperative analgesia. We hypothesize that epidural analgesia will be favorable to both piritramide-based and morphine-based analgesia and that piritramide-based analgesia will be favorable to morphine-based analgesia with regard to the number of circulating cancer cells and its development in the early postoperative period.
Read the detailed description
Techniques of regional analgesia such as epidural analgesia may favorably influence metastasis development following cancer surgery compared to analgesia based on strong opioids such as morphine or piritramide. These beneficial effects, if present, are probably attributable to less immunosuppression of antimetastatic immune defenses.
The aim of this study is to identify techniques of perioperative analgesia with the potential to prevent metastasis development in patients undergoing open radical colon cancer surgery. In the early postoperative period, a relationship between metastasis development and the number of circulating cancer cells representing minimal residual disease has been shown. Therefore, effects of epidural, morphine-based and piritramide-based analgesia on the number of circulating cancer cells will be compared at several time points during the peroperative and early postoperative periods. The number of circulating cancer cells will be assessed in peripheral venous blood samples using real-time polymerase chain reaction. Perioperative care will be standardized and patients will be followed by clinical observation, laboratory analyses and monitoring instrumentation daily during their hospital stay.
- Conditions
- Colon Cancer, Minimal Residual Disease
- Being tested
- Epidural analgesia, Piritramide, Morphine
- Keywords
- perioperative analgesia, minimal residual disease, cancer recurrence, epidural, morphine, piritramide, colon, cancer, circulating cancer cells, colon cancer surgery
- Medical subject headings
- Colonic Neoplasms, Neoplasm, Residual, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural analgesiaOther
Also called Perioperative epidural analgesia
see Arm/group description
PiritramideDrug
Also called Postoperative piritramide analgesia
see Arm/group description
MorphineDrug
Also called Postoperative morphine analgesia
see Arm/group description
| Study group | Role | What they receive |
|---|---|---|
| Epidural | Active comparator | Patients will receive perioperative epidural analgesia. Drugs: bupivacaine 1.25 mg/ml and sufentanil 0.5 mcg/ml Form and frequency: continuous infusion Dosage: 4 - 14 ml/h with boluses 2 - 4 ml based on pain assessment Duration: as long as required Receives: Other: Epidural analgesia |
| Piritramide | Active comparator | Patients will receive postoperative analgesia with piritramide. Drugs: piritramide 1.0 mg/ml Form and frequency: continuous infusion Dosage: 0 - 4 ml/h with boluses 2 - 4 ml based on pain assessment Duration: as long as required Receives: Drug: Piritramide |
| Morphine | Active comparator | Patients will receive postoperative analgesia with morphine. Drugs: morphine 1.0 mg/ml Form and frequency: continuous infusion Dosage: 0 - 4 ml/h with boluses 2 - 4 ml based on pain assessment Duration: as long as required Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline number of circulating cancer cells at 3 weeks after surgery
Number of circulating cancer cells will be measured in venous blood samples. The quantitative real-time polymerase chain reaction using carcinoembryonic antigen and cytokeratine 20 as markers for circulating cancer cells will be used for minimal residual disease detection.
Measured: Baseline prior to surgery, on day 2 postoperatively and three weeks after surgery
Secondary outcomes (1)
Pain intensity assessment
Self reported pain intensity. Scale: 0 = no pain, 10 = worst pain imaginable. A score 0-10 will be recorded every four hours.
Measured: 3 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionMar 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Institute of Molecular and Translational Medicine, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- Brno University Hospital, Tomas Bata Hospital, Czech Republic
- Responsible party
- Principal investigator, Marian Hajduch, M.D., Ph.D., The Institute of Molecular and Translational Medicine, Czech Republic
- Investigators
- Emil Berta, MD PhD, Principal investigator, The Institute of Molecular and Translational Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02314871
- Sponsor's protocol ID
- CAREC-1
- Status last verified
- Mar 2019
- First submitted
- 1 Dec 2014
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Types of Perioperative Analgesia on Minimal Residual Disease Development After Colon Cancer Surgery
- ClinicalTrials.gov ID
- NCT02314871
- Acronym / sponsor ID
- CAREC-1
- Conditions
- Colon Cancer, Minimal Residual Disease
- Keywords
- perioperative analgesia, minimal residual disease, cancer recurrence, epidural, morphine, piritramide, colon, cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Institute of Molecular and Translational Medicine, Czech RepublicUniversity, hospital or other
- Collaborators
- Brno University Hospital, Tomas Bata Hospital, Czech Republic
- Study start
- Jan 2015
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 11 Dec 2014 (estimated)
- 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.
The aim of this study is to compare the effects of three types of perioperative analgesia on the number of circulating cancer cells (representing minimal residual disease) following radical colon cancer surgery. Patients will be randomized into one of three groups. The intervention group will receive combined regional and general anesthesia during surgery and postoperative epidural analgesia. The two control groups will receive balanced general anesthesia and either morphine-based or piritramide-based postoperative analgesia. We hypothesize that epidural analgesia will be favorable to both piritramide-based and morphine-based analgesia and that piritramide-based analgesia will be favorable to morphine-based analgesia with regard to the number of circulating cancer cells and its development in the early postoperative period.
Detailed description
Techniques of regional analgesia such as epidural analgesia may favorably influence metastasis development following cancer surgery compared to analgesia based on strong opioids such as morphine or piritramide. These beneficial effects, if present, are probably attributable to less immunosuppression of antimetastatic immune defenses.
The aim of this study is to identify techniques of perioperative analgesia with the potential to prevent metastasis development in patients undergoing open radical colon cancer surgery. In the early postoperative period, a relationship between metastasis development and the number of circulating cancer cells representing minimal residual disease has been shown. Therefore, effects of epidural, morphine-based and piritramide-based analgesia on the number of circulating cancer cells will be compared at several time points during the peroperative and early postoperative periods. The number of circulating cancer cells will be assessed in peripheral venous blood samples using real-time polymerase chain reaction. Perioperative care will be standardized and patients will be followed by clinical observation, laboratory analyses and monitoring instrumentation daily during their hospital stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Epidural | Active comparator | Other: Epidural analgesiaPatients will receive perioperative epidural analgesia. Drugs: bupivacaine 1.25 mg/ml and sufentanil 0.5 mcg/ml Form and frequency: continuous infusion Dosage: 4 - 14 ml/h with boluses 2 - 4 ml based on pain assessment Duration: as long as required |
| Piritramide | Active comparator | Drug: PiritramidePatients will receive postoperative analgesia with piritramide. Drugs: piritramide 1.0 mg/ml Form and frequency: continuous infusion Dosage: 0 - 4 ml/h with boluses 2 - 4 ml based on pain assessment Duration: as long as required |
| Morphine | Active comparator | Drug: MorphinePatients will receive postoperative analgesia with morphine. Drugs: morphine 1.0 mg/ml Form and frequency: continuous infusion Dosage: 0 - 4 ml/h with boluses 2 - 4 ml based on pain assessment Duration: as long as required |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing open radical surgery for colon cancer (without known extension beyond colon)
- Age over 18 years
- Written informed consent
Key exclusion criteria (7 listed)
- Allergy or intolerance of morphine, piritramide, marcaine, sufentanil or volatile anesthetics
- History of colon cancer resection
- Other cancer present (apart from those in complete long-term remission for minimum 6 months)
- Chronic opioid medication and/or opioid administration 7 days or less prior to surgery
- Any contraindication to thoracic epidural anesthesia/analgesia
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 |
|---|---|---|
| Epidural analgesiaAlso: Perioperative epidural analgesiasee Arm/group description | Other | Epidural |
| PiritramideAlso: Postoperative piritramide analgesiasee Arm/group description | Drug | Piritramide |
| MorphineAlso: Postoperative morphine analgesiasee Arm/group description | Drug | Morphine |
Primary outcome
Change from baseline number of circulating cancer cells at 3 weeks after surgery
Time frame: Baseline prior to surgery, on day 2 postoperatively and three weeks after surgery
Number of circulating cancer cells will be measured in venous blood samples. The quantitative real-time polymerase chain reaction using carcinoembryonic antigen and cytokeratine 20 as markers for circulating cancer cells will be used for minimal residual disease detection.
1 secondary outcome
Pain intensity assessment
Time frame: 3 days postoperatively
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 13 Mar 2019.
- The Institute of Molecular and Translational Medicine, Faculty of Medicine and Dentistry Palacky University OlomoucLink provided by the sponsor.
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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.
Emil Berta, MD PhD principal investigator
The Institute of Molecular and Translational Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Epidural analgesia, Piritramide and Morphine in people with Colon Cancer and Minimal Residual Disease, run by The Institute of Molecular and Translational Medicine, Czech Republic at 2 sites in Czechia.
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 7 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 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change from baseline number of circulating cancer cells at 3 weeks after surgery (time frame: Baseline prior to surgery, on day 2 postoperatively and three weeks after surgery). 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 13 Mar 2019.