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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Saline

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.

• Study Type: Interventional
• Enrollment (Actual): 148
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Renji Hospital, School of Medicine, Shanghai Jiaotong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Drug: Dexmedetomidine; Patients in the experimental group will receive Dexmedetomidine during surgery.
PLACEBO_COMPARATOR: saline; Same amount of saline will be administrated.	Drug: Saline; Patients in the control group will receive saline but not Dexmedetomidine during surgery.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: RenJi Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2016
• Primary Completion (ACTUAL): September 30, 2021
• Study Completion (ACTUAL): September 30, 2021

Study Registration Dates

• First Submitted: March 11, 2017
• First Submitted That Met QC Criteria: April 6, 2017
• First Posted (ACTUAL): April 12, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 10, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Neoplasms by Site; Disease Attributes; Breast Diseases; Breast Neoplasms; Recurrence; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: DEX20161020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No