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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Pilot Study to Evaluate the Impact of Dexmedetomidine on Postoperative Tumor Recurrence in Patients With Primary Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine<br>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. | Drug: Dexmedetomidine<br>* Patients in the experimental group will receive Dexmedetomidine during surgery.<br>|
| Placebo Comparator: saline<br>Same amount of saline will be administrated. | Drug: Saline<br>* Patients in the control group will receive saline but not Dexmedetomidine during surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| study feasibility | recruitment and dropout rates | from May 2015 to August 2019 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence-free survival | time from surgery to the earliest date of recurrence/metastasis | up to 5 years after surgery | 
| overall survival | time from surgery to the date of all-cause death | up to 5 years after surgery | 
| the number of blood CD3+ cells |  | at 24 hours after surgery | 
| the number/percentage of blood CD4+ cells |  | at 24 hours after surgery | 
| the number/percentage of blood CD8+ cells |  | at 24 hours after surgery | 
| the number/percentage of blood NK cells |  | at 24 hours after surgery | 
| the ratio of CD4+ cells / CD8+ cells |  | at 24 hours after surgery | 
| the number/percentage of blood CD19+ cells |  | at 24 hours after surgery |