NCT01692210

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

September 19, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 25, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

January 7, 2016

Status Verified

January 1, 2016

Enrollment Period

2.4 years

First QC Date

September 19, 2012

Last Update Submit

January 5, 2016

Conditions

Breast Cancer

Keywords

Breast CancerDexmedetomidineUnilateral mastectomyBlood sample collectionsImmune systemWhite blood cell levels

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 days

Study Arms (1)

Blood Draw Pre and Post Surgery

Patients within the UT MD Anderson Cancer Center who are scheduled for breast cancer surgery.

Drug: Dexmedetomidine

Interventions

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.

Blood Draw Pre and Post Surgery

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Women undergoing unilateral mastectomy for malignancy at MD Anderson Cancer Center in Houston, Texas.

You may qualify if:

  • Women undergoing unilateral mastectomy for malignancy at MD Anderson Cancer Center.
  • Patients 18 years of age and older. There will be no upper age restriction.
  • Patients must sign a study-specific consent form.

You may not qualify if:

  • ASA 4
  • Contraindication to the use of dexmedetomidine.
  • Decompensated congestive heart failure.
  • Second and third degree heart block.
  • Known allergy to dexmedetomidine or any of the medications used in the study
  • Patients taking clonidine for treatment of arterial hypertension.
  • Patients that are pregnant.
  • Patients taking opioids at the time of surgery.
  • Patients having plastic surgical reconstruction.
  • Recent chemotherapy (\< 4 weeks).
  • Active autoimmune or immunological disease including but not limited to systemic lupus erythematous, rheumatoid arthritis and Sjogren's disease
  • Patient refusal to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

15cc of blood drawn prior or at the moment of anesthesia induction and the morning after surgery.

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Juan P. Cata, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2012

First Posted

September 25, 2012

Study Start

September 1, 2012

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

January 7, 2016

Record last verified: 2016-01

Locations

US(1)