InflammationPhase 2/3NCT04106999
Dexmedetomidine and HIPEC
A Phase 2/3 study testing Dexmedetomidine in people with Inflammation and Cancer, run by University of British Columbia at 1 site in Canada.
Trial summary
Inflammation is associated with an increased risk of cancer recurrence. Various methods have been used to decrease the inflammatory response induced by the cancer and surgery. In this study the investigators would like determine if a commonly used sedative drug (dexmedtomidine) has an impact on this inflammatory state… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Cancer
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2023to Dec 2024
- Phase
- Phase 2/3
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing a Hyperthermic Intraperitoneal Chemotherapy (HIPEC) procedure as part of their cancer treatment at Vancover General Hospital
- 18 years of age or older
- Able to provide informed consent
- Expected stay 5 days or greater in hospital
- Presenting for HIPEC with Colon or Appendix Cancer
Who cannot join
- Contraindication to dexmedtomidine use including allergy or sensitivity to the drug
- Pregnancy
- Dementia
- ASA greater than or equal to 4
- Significant liver disease
- Current use of steroid or immunosuppressive medication
Show all 10Show fewer
- Mesothelioma tumour origin
- Current use of clonidine
- Current opioid use exceeding 30mg of oral morphine equivalents
- Patient not eligible or patient refusal to have a thoracic epidural
Trial locations and contacts
1 site in 1 country.
Canada1 site
UBC/Medicine, Faculty of/Anesthesiology, Pharmacology & Therapeutics
Vancouver, British Columbia, V5Z 1L8
About this study
Official title: Dexmedetomidine and Inflammation in HIPEC Cases: A Case Series
Inflammation is associated with an increased risk of cancer recurrence. Various methods have been used to decrease the inflammatory response induced by the cancer and surgery. In this study the investigators would like determine if a commonly used sedative drug (dexmedtomidine) has an impact on this inflammatory state when used as part of the anesthetic. The investigators will conduct a pilot study with 20 patients undergoing a Hyperthermic Intraperitoneal Chemotherapy (HIPEC) procedure as part of their cancer treatment. 10 patients will receive the standard of care for anesthesia during the cancer surgery and a placebo infusion of normal saline at a rate consistent to that of the study drug. 10 additional patients will receive the same standard of care anesthetic plan with the addition of an infusion of dexmeditomidine during the procedure. The investigators will measure the degree of inflammation before, during and after the surgical procedure by looking at the levels of inflammatory markers in blood samples. The goal is to determine if the addition of dexmodtomidine affects the inflammatory state of patients undergoing a HIPEC procedure. This information will be used to guide future studies aiming at decreasing cancer recurrence and improve patient outcomes.
Read the detailed description
Purpose: To investigate the use of intra-operative dexmedetomidine infusions to reduce the inflammatory and stress response of cytoreductive treatment and hyperthermic intra-peritoneal chemotherapy (HIPEC).
Hypothesis: HIPEC surgery patients who receive an intra-operative infusion of dexmedetomidine in addition to the current standard of care, consisting of parenteral and enteral opioids and thoracic epidural will have a reduction in their inflammatory markers intra-operatively, in PACU, POD1 and POD5 and a reduction in oral morphine equivalent opioid consumption in PACU and POD1, in comparison to those who receive a placebo infusion.
Justification: Surgical tumor excision is a cornerstone of primary cancer treatment, but is also recognized as one of the greatest risk factors for metastatic spread. The perioperative period, characterized by the surgical stress response and pharmacologic-induced angiogenesis and immunomodulation, results in a physiologic environment that supports tumor spread and distant reimplantation. There is potential for anesthesiologists to modulate the unwanted consequences of the stress response on the immune system and minimize residual disease by altering their anesthetic plan.
Dexmedtomidine is a commonly used sedative that can be used as part of an anesthetic during surgery. In vitro and animal studies have shown that dexmedtomidine decreases the inflammatory response but no research has been conducted with cancer-related conditions.
Objective: To determine if dexmedtomidine, when used intraoperatively, can decrease the levels of inflammation in patients a Hyperthermic Intraperitoneal Chemotherapy (HIPEC) procedure as part of their cancer treatment.
Primary Objective:
Reduction in inflammatory markers: CRP, ESR, NLR, PLR, plasma viscosity, lactate.
Secondary Objectives Reduction in Cancer markers: CEA (carcinoembyronic antigen] and CA19-9 Reduction in opioid use Reduction in volatile usage (average sevoflurane end-tidal level)
Research Design: In this pilot study, 20 patients undergoing a HIPEC procedure as part of their cancer treatment will be randomized into 2 groups. One group (controls) will receive the current anesthetic standard of care. The second group (experimental) will also receive the current anesthetic standard of care with the addition of an infusion of dexmedtomidine during the surgical procedure. Biomarkers of inflammation (Lactate, CRP, ESR, plasma viscosity, NLR, PLR, and procalcitonin) and cancer markers (CEA and CA19-9) will be measured at 5 time points: pre-operatively, intra-opertatively prior to chemotherapy, post-operatively in the post-anaesthetic care unit, post-operative day 1, and post-operative day 5. Quantitative analysis of the inflammatory markers will be used to compare the two groups.
Statistical Analysis: Data will be summarized and t-tests will be used to compare the data from the 2 groups.
- Conditions
- Inflammation, Cancer
- Being tested
- Dexmedetomidine, Placebos
- Medical subject headings
- Inflammation, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Drug infusion will be delivered intra-operatively
PlacebosDrug
Normal Saline will be infused as a control drug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Normal Saline will be infused as per the protocol Receives: Drug: Placebos |
| Intervention group | Experimental | Dexmedetomidine will be infused as per the protocol Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammation
Reduction in inflammatory markers: CRP, ESR, NLR, PLR, plasma viscosity, lactate.
Measured: 5 days
Secondary outcomes (3)
Cancer recurrance
Reduction in Cancer markers: CEA (carcinoembyronic antigen] and CA19-9
Measured: 5 days
Anesthesia Dose
Reduction in volatile usage (average sevoflurane end-tidal level)
Measured: 5 days
Opioid use
Reduction in opioid use
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study startMar 2023 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1 group will receive placebo drug delivery (Normal Saline infusion). The 2nd group will receive the study drug infusion (Dexmedetomidine)
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Wilson, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04106999
- Sponsor's protocol ID
- H19-00859
- Status last verified
- Nov 2022
- First submitted
- 25 Sep 2019
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We may publish this research and share at a conference or through a research paper
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine and Inflammation in HIPEC Cases: A Case Series
- ClinicalTrials.gov ID
- NCT04106999
- Acronym / sponsor ID
- H19-00859
- Conditions
- Inflammation, Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Mar 2023 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 27 Sep 2019 (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.
Inflammation is associated with an increased risk of cancer recurrence. Various methods have been used to decrease the inflammatory response induced by the cancer and surgery. In this study the investigators would like determine if a commonly used sedative drug (dexmedtomidine) has an impact on this inflammatory state when used as part of the anesthetic. The investigators will conduct a pilot study with 20 patients undergoing a Hyperthermic Intraperitoneal Chemotherapy (HIPEC) procedure as part of their cancer treatment. 10 patients will receive the standard of care for anesthesia during the cancer surgery and a placebo infusion of normal saline at a rate consistent to that of the study drug. 10 additional patients will receive the same standard of care anesthetic plan with the addition of an infusion of dexmeditomidine during the procedure. The investigators will measure the degree of inflammation before, during and after the surgical procedure by looking at the levels of inflammatory markers in blood samples. The goal is to determine if the addition of dexmodtomidine affects the inflammatory state of patients undergoing a HIPEC procedure. This information will be used to guide future studies aiming at decreasing cancer recurrence and improve patient outcomes.
Detailed description
Purpose: To investigate the use of intra-operative dexmedetomidine infusions to reduce the inflammatory and stress response of cytoreductive treatment and hyperthermic intra-peritoneal chemotherapy (HIPEC).
Hypothesis: HIPEC surgery patients who receive an intra-operative infusion of dexmedetomidine in addition to the current standard of care, consisting of parenteral and enteral opioids and thoracic epidural will have a reduction in their inflammatory markers intra-operatively, in PACU, POD1 and POD5 and a reduction in oral morphine equivalent opioid consumption in PACU and POD1, in comparison to those who receive a placebo infusion.
Justification: Surgical tumor excision is a cornerstone of primary cancer treatment, but is also recognized as one of the greatest risk factors for metastatic spread. The perioperative period, characterized by the surgical stress response and pharmacologic-induced angiogenesis and immunomodulation, results in a physiologic environment that supports tumor spread and distant reimplantation. There is potential for anesthesiologists to modulate the unwanted consequences of the stress response on the immune system and minimize residual disease by altering their anesthetic plan.
Dexmedtomidine is a commonly used sedative that can be used as part of an anesthetic during surgery. In vitro and animal studies have shown that dexmedtomidine decreases the inflammatory response but no research has been conducted with cancer-related conditions.
Objective: To determine if dexmedtomidine, when used intraoperatively, can decrease the levels of inflammation in patients a Hyperthermic Intraperitoneal Chemotherapy (HIPEC) procedure as part of their cancer treatment.
Primary Objective:
Reduction in inflammatory markers: CRP, ESR, NLR, PLR, plasma viscosity, lactate.
Secondary Objectives Reduction in Cancer markers: CEA (carcinoembyronic antigen] and CA19-9 Reduction in opioid use Reduction in volatile usage (average sevoflurane end-tidal level)
Research Design: In this pilot study, 20 patients undergoing a HIPEC procedure as part of their cancer treatment will be randomized into 2 groups. One group (controls) will receive the current anesthetic standard of care. The second group (experimental) will also receive the current anesthetic standard of care with the addition of an infusion of dexmedtomidine during the surgical procedure. Biomarkers of inflammation (Lactate, CRP, ESR, plasma viscosity, NLR, PLR, and procalcitonin) and cancer markers (CEA and CA19-9) will be measured at 5 time points: pre-operatively, intra-opertatively prior to chemotherapy, post-operatively in the post-anaesthetic care unit, post-operative day 1, and post-operative day 5. Quantitative analysis of the inflammatory markers will be used to compare the two groups.
Statistical Analysis: Data will be summarized and t-tests will be used to compare the data from the 2 groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- 1 group will receive placebo drug delivery (Normal Saline infusion). The 2nd group will receive the study drug infusion (Dexmedetomidine)
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlacebosNormal Saline will be infused as per the protocol |
| Intervention group | Experimental | Drug: DexmedetomidineDexmedetomidine will be infused as per the protocol |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients undergoing a Hyperthermic Intraperitoneal Chemotherapy (HIPEC) procedure as part of their cancer treatment at Vancover General Hospital
- 18 years of age or older
- Able to provide informed consent
- Expected stay 5 days or greater in hospital
- Presenting for HIPEC with Colon or Appendix Cancer
Key exclusion criteria (10 listed)
- Contraindication to dexmedtomidine use including allergy or sensitivity to the drug
- Pregnancy
- Dementia
- ASA greater than or equal to 4
- Significant liver disease
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 |
|---|---|---|
| DexmedetomidineDrug infusion will be delivered intra-operatively | Drug | Intervention group |
| PlacebosNormal Saline will be infused as a control drug | Drug | Placebo |
Primary outcome
Inflammation
Time frame: 5 days
Reduction in inflammatory markers: CRP, ESR, NLR, PLR, plasma viscosity, lactate.
3 secondary outcomes
Cancer recurrance
Time frame: 5 days
Anesthesia Dose
Time frame: 5 days
Opioid use
Time frame: 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Individual participant dataSharing planned: Undecided. We may publish this research and share at a conference or through a research paper
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dexmedetomidine in people with Inflammation and Cancer, run by University of British Columbia at 1 site in Canada.
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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 3 Nov 2022. 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 Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Inflammation (time frame: 5 days). 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 3 Nov 2022.