Breast CancerNCT01692210
The Effect of Dexmedetomidine of the Immune System
An observational study of Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this research study is to learn about how dexmedetomidine (a standard of care sedative) affects your immune system (your defenses against cancer) by measuring your white blood cell levels before and after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Feb 2015
- Phase
- Observational
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women undergoing unilateral mastectomy for malignancy at MD Anderson Cancer Center in Houston, Texas.
Who may be able to join
- 3.1.1 - Women undergoing unilateral mastectomy for malignancy at MD Anderson Cancer Center.
- 3.1.2 - Patients 18 years of age and older. There will be no upper age restriction.
- 3.1.3 - Patients must sign a study-specific consent form.
Who cannot join
- 3.2.1 - ASA 4
- 3.2.2 - Contraindication to the use of dexmedetomidine.
- 3.2.2.1. Decompensated congestive heart failure.
- 3.2.2.2. Second and third degree heart block.
- 3.2.2.2. Known allergy to dexmedetomidine or any of the medications used in the study
- 3.2.3 - Patients taking clonidine for treatment of arterial hypertension.
Show all 12Show fewer
- 3.2.4 - Patients that are pregnant.
- 3.2.5 - Patients taking opioids at the time of surgery.
- 3.2.6 - Patients having plastic surgical reconstruction.
- 3.2.7 - Recent chemotherapy (< 4 weeks).
- 3.2.8 - Active autoimmune or immunological disease including but not limited to systemic lupus erythematous, rheumatoid arthritis and Sjogren's disease
- 3.2.9 - Patient refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: The Effect of Dexmedetomidine on Immunological Parameters of Women Undergoing Breast Cancer Surgery
The goal of this research study is to learn about how dexmedetomidine (a standard of care sedative) affects your immune system (your defenses against cancer) by measuring your white blood cell levels before and after surgery.
Read the detailed description
Dexmedetomidine is a type of sedative used as part of anesthetic care. It is sometimes used to help lower the amount of pain killers and other anesthetics that are given to a patient during surgery. Researchers want to study how this drug works in cancer patients and review the patient's chart for pain levels and medication use after surgery. Part of this research involves studying the immune system of surgery patients.
If you agree to take part in this study, blood (about 1 tablespoon) will be drawn before you have surgery and the morning after surgery while you are still in the hospital. This blood will be used to learn more about how your immune system works.
After your second blood draw, your participation in this study will be over.
This is an investigational study.
Up to 20 participants will be enrolled in this study. All will take part at MD Anderson.
- Conditions
- Breast Cancer
- Being tested
- Dexmedetomidine
- Keywords
- Breast Cancer, Dexmedetomidine, Unilateral mastectomy, Blood sample collections, Immune system, White blood cell levels
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
After induction of general anesthesia, a loading dose of dexmedetomidine (1 mcg/kg) given in 15 min followed by an infusion of the same medication at a rate of 0.4 - 0.7 mcg/kg/hour.
| Study group | Role | What they receive |
|---|---|---|
| Blood Draw Pre and Post Surgery | Patients within the UT MD Anderson Cancer Center who are scheduled for breast cancer surgery. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre and Post Surgical Lymphocyte Counts
Lymphocyte counts determined by flow-cytometry and their function by cytotoxicity assays performed in the laboratory using samples obtained before and the morning after surgery. Patients who experience a reduction of less than 50% of their preoperative natural killer cell (NKC) activity considered as a success.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Hospira, now a wholly owned subsidiary of Pfizer
- Responsible party
- Sponsor
- Investigators
- Juan P. Cata, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01692210
- Sponsor's protocol ID
- PA12-0524
- Status last verified
- Jan 2016
- First submitted
- 19 Sep 2012
- Last updated
- 7 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dexmedetomidine on Immunological Parameters of Women Undergoing Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT01692210
- Acronym / sponsor ID
- PA12-0524
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Dexmedetomidine, Unilateral mastectomy, Blood sample collections, Immune system, White blood cell levels
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Hospira, now a wholly owned subsidiary of Pfizer
- Study start
- Sep 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 25 Sep 2012 (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 goal of this research study is to learn about how dexmedetomidine (a standard of care sedative) affects your immune system (your defenses against cancer) by measuring your white blood cell levels before and after surgery.
Detailed description
Dexmedetomidine is a type of sedative used as part of anesthetic care. It is sometimes used to help lower the amount of pain killers and other anesthetics that are given to a patient during surgery. Researchers want to study how this drug works in cancer patients and review the patient's chart for pain levels and medication use after surgery. Part of this research involves studying the immune system of surgery patients.
If you agree to take part in this study, blood (about 1 tablespoon) will be drawn before you have surgery and the morning after surgery while you are still in the hospital. This blood will be used to learn more about how your immune system works.
After your second blood draw, your participation in this study will be over.
This is an investigational study.
Up to 20 participants will be enrolled in this study. All will take part at MD Anderson.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood Draw Pre and Post Surgery | – | Drug: DexmedetomidinePatients within the UT MD Anderson Cancer Center who are scheduled for breast cancer surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women undergoing unilateral mastectomy for malignancy at MD Anderson Cancer Center in Houston, Texas.
Key inclusion criteria (3 listed)
- 3.1.1 - Women undergoing unilateral mastectomy for malignancy at MD Anderson Cancer Center.
- 3.1.2 - Patients 18 years of age and older. There will be no upper age restriction.
- 3.1.3 - Patients must sign a study-specific consent form.
Key exclusion criteria (12 listed)
- 3.2.1 - ASA 4
- 3.2.2 - Contraindication to the use of dexmedetomidine.
- 3.2.2.1. Decompensated congestive heart failure.
- 3.2.2.2. Second and third degree heart block.
- 3.2.2.2. Known allergy to dexmedetomidine or any of the medications used in the study
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 |
|---|---|---|
| DexmedetomidineAfter induction of general anesthesia, a loading dose of dexmedetomidine (1 mcg/kg) given in 15 min followed by an infusion of the same medication at a rate of 0.4 - 0.7 mcg/kg/hour. | Drug | Blood Draw Pre and Post Surgery |
Primary outcome
Pre and Post Surgical Lymphocyte Counts
Time frame: 2 days
Lymphocyte counts determined by flow-cytometry and their function by cytotoxicity assays performed in the laboratory using samples obtained before and the morning after surgery. Patients who experience a reduction of less than 50% of their preoperative natural killer cell (NKC) activity considered as a success.
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 7 Jan 2016.
- University of Texas MD Anderson Cancer Center WebsiteLink 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.
Juan P. Cata, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
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 12 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 7 Jan 2016. 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 United States. 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?
Pre and Post Surgical Lymphocyte Counts (time frame: 2 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 7 Jan 2016.