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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03109990
• Other study ID #: DEX20161020
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: September 30, 2021

Study information

• Verified date: November 2022
• Source: RenJi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Recurrence

Intervention

Drug:
• Dexmedetomidine
Patients in the experimental group will receive Dexmedetomidine during surgery.
• Saline
Patients in the control group will receive saline but not Dexmedetomidine during surgery.

Locations

Country	Name	City	State
China	Renji hospital, School of Medicine, Shanghai Jiaotong University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	study feasibility	recruitment and dropout rates	from May 2015 to August 2019
Secondary	recurrence-free survival	time from surgery to the earliest date of recurrence/metastasis	up to 5 years after surgery
Secondary	overall survival	time from surgery to the date of all-cause death	up to 5 years after surgery
Secondary	the number of blood CD3+ cells		at 24 hours after surgery
Secondary	the number/percentage of blood CD4+ cells		at 24 hours after surgery
Secondary	the number/percentage of blood CD8+ cells		at 24 hours after surgery
Secondary	the number/percentage of blood NK cells		at 24 hours after surgery
Secondary	the ratio of CD4+ cells / CD8+ cells		at 24 hours after surgery
Secondary	the number/percentage of blood CD19+ cells		at 24 hours after surgery