search
Back to results

A Pilot Study to Evaluate the Impact of Dexmedetomidine on Breast Cancer Recurrence After Surgery

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Dexmedetomidine
Saline
Sponsored by
RenJi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA grade I-III
  • Age range of 18 to75
  • Patients diagnosed primary breast cancer
  • Patients will have elective mastectomy

Exclusion Criteria:

  • with history of breast operation
  • Patients diagnosed with inflammatory breast
  • Severe mental or physical illnesses(like liver, renal, brain or lung disease)
  • with history of opioid addiction
  • Patients diagnosed metastatic breast cancer
  • Contradictions or an allergy to Dexmedetomidine

Sites / Locations

  • Renji hospital, School of Medicine, Shanghai Jiaotong University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dexmedetomidine

saline

Arm Description

Patients of dexmedetomidine group will receive a loading dose of 1ug/kg dexmedetomidine since 15 mins before induction, and receive another 1ug/kg of dexmedetomidine at a rate of 0.5ug/kg/h for 2 continuous hours during surgery.

Same amount of saline will be administrated.

Outcomes

Primary Outcome Measures

study feasibility
recruitment and dropout rates

Secondary Outcome Measures

recurrence-free survival
time from surgery to the earliest date of recurrence/metastasis
overall survival
time from surgery to the date of all-cause death
the number of blood CD3+ cells
the number/percentage of blood CD4+ cells
the number/percentage of blood CD8+ cells
the number/percentage of blood NK cells
the ratio of CD4+ cells / CD8+ cells
the number/percentage of blood CD19+ cells

Full Information

First Posted
March 11, 2017
Last Updated
November 7, 2022
Sponsor
RenJi Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03109990
Brief Title
A Pilot Study to Evaluate the Impact of Dexmedetomidine on Breast Cancer Recurrence After Surgery
Official Title
A Pilot Study to Evaluate the Impact of Dexmedetomidine on Postoperative Tumor Recurrence in Patients With Primary Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RenJi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Dexmedetomidine is widely used as an anaesthetic for general anesthesia during surgery. Previous studies in cells and animals show that dexmedetomidine may promote cancer growth. The purpose of present study is to examine whether utilization of dexmedetomidine in patients undergoing surgery for primary breast cancer increases breast cancer recurrence and metastasis, and to investigate its effects on the patients' immune system.
Detailed Description
Women diagnosed with breast cancer undergoing elective surgery under general anesthesia will be randomly allocated to dexmedetomidine group or control group. Patients from both groups will receive midazolam, propofol, fentanyl, remifentanil and CIS atracurium for total intravenous anesthesia. BIS value will be controlled between 40-60 during surgery. Patients of dexmedetomidine group will receive a loading does of 1ug/kg dexmedetomidine since 15 mins before induction, and receive another 1ug/kg of dexmedetomidine at a rate of 0.5ug/kg/h for 2 continuous hours during surgery. Patients of control group will receive same amount of normal saline. Patients will be followed up for 36 months to measure the incidence of cancer recurrence and metastasis. Serum form patients of both groups will be collected at 24 h after surgery. The number of CD3+ , CD4+, CD8+ cells and NK cells in the serum will be compared between the two groups. Serum levels of IFN-γ, IL-12，IL-4 and VEGF will also be measured and compared.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
148 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine
Arm Type
Experimental
Arm Description
Patients of dexmedetomidine group will receive a loading dose of 1ug/kg dexmedetomidine since 15 mins before induction, and receive another 1ug/kg of dexmedetomidine at a rate of 0.5ug/kg/h for 2 continuous hours during surgery.
Arm Title
saline
Arm Type
Placebo Comparator
Arm Description
Same amount of saline will be administrated.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
Patients in the experimental group will receive Dexmedetomidine during surgery.
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
Patients in the control group will receive saline but not Dexmedetomidine during surgery.
Primary Outcome Measure Information:
Title
study feasibility
Description
recruitment and dropout rates
Time Frame
from May 2015 to August 2019
Secondary Outcome Measure Information:
Title
recurrence-free survival
Description
time from surgery to the earliest date of recurrence/metastasis
Time Frame
up to 5 years after surgery
Title
overall survival
Description
time from surgery to the date of all-cause death
Time Frame
up to 5 years after surgery
Title
the number of blood CD3+ cells
Time Frame
at 24 hours after surgery
Title
the number/percentage of blood CD4+ cells
Time Frame
at 24 hours after surgery
Title
the number/percentage of blood CD8+ cells
Time Frame
at 24 hours after surgery
Title
the number/percentage of blood NK cells
Time Frame
at 24 hours after surgery
Title
the ratio of CD4+ cells / CD8+ cells
Time Frame
at 24 hours after surgery
Title
the number/percentage of blood CD19+ cells
Time Frame
at 24 hours after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA grade I-III Age range of 18 to75 Patients diagnosed primary breast cancer Patients will have elective mastectomy Exclusion Criteria: with history of breast operation Patients diagnosed with inflammatory breast Severe mental or physical illnesses(like liver, renal, brain or lung disease) with history of opioid addiction Patients diagnosed metastatic breast cancer Contradictions or an allergy to Dexmedetomidine
Facility Information:
Facility Name
Renji hospital, School of Medicine, Shanghai Jiaotong University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

A Pilot Study to Evaluate the Impact of Dexmedetomidine on Breast Cancer Recurrence After Surgery

We'll reach out to this number within 24 hrs