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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Saline; Drug: Dexmedetomidine

• Registration Number: NCT03109990
• Lead Sponsor: RenJi Hospital

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2017-03-11
• Study First Submitted QC: 2017-04-06
• Study First Posted: 2017-04-12
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-07
• Last Update Posted: 2022-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 148

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
saline	Saline	Same amount of saline will be administrated.
Dexmedetomidine	Dexmedetomidine	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.

Primary Outcome Measures

Name	Time	Method
study feasibility	from May 2015 to August 2019	recruitment and dropout rates

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Renji hospital, School of Medicine, Shanghai Jiaotong University; 🇨🇳 Shanghai, Shanghai, China