Clinical trial NCT03109990: 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
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2017-04-12
Enrollment: 148
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: study feasibility
timeFrame: from May 2015 to August 2019
Secondary outcomes:
measure: recurrence-free survival
timeFrame: up to 5 years after surgery
measure: overall survival
timeFrame: up to 5 years after surgery
measure: the number of blood CD3+ cells
timeFrame: at 24 hours after surgery
measure: the number/percentage of blood CD4+ cells
timeFrame: at 24 hours after surgery
measure: the number/percentage of blood CD8+ cells
timeFrame: at 24 hours after surgery
measure: the number/percentage of blood NK cells
timeFrame: at 24 hours after surgery
measure: the ratio of CD4+ cells / CD8+ cells
timeFrame: at 24 hours after surgery
measure: the number/percentage of blood CD19+ cells
timeFrame: at 24 hours after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji hospital, School of Medicine, Shanghai Jiaotong University
state: Shanghai
Study officials:
References: