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Effects of Dexmedetomidine on Breast Cancer Cell Function in Vitro

NCT ID: NCT03108937

Last Updated: 2017-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-12

Study Completion Date

2017-09-08

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. Using serum from breast cancer surgery patients randomized to receive dexmedetomidine or saline during surgery, we investigated the effects of dexmedetomidine on proliferation, migration and metastasis in MCF-7 breast cancer cells in vitro.

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. Serum will be collected from patients of both groups at before induction and 1h post-surgery. The MCF-7 breast cancer cell line will be treated with patient serum from both groups. The effects of dexmedetomidine on cellular proliferation, migration and metastasis will be measured.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Dexmedetomidine

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.

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

Patients in the experimental group will receive Dexmedetomidine during surgery.

saline

Same amount of saline will be administrated.

Group Type PLACEBO_COMPARATOR

saline

Intervention Type DRUG

Patients in the control group will receive saline but not Dexmedetomidine during surgery.

Interventions

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Dexmedetomidine

Patients in the experimental group will receive Dexmedetomidine during surgery.

Intervention Type DRUG

saline

Patients in the control group will receive saline but not Dexmedetomidine during surgery.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ASA grade I-III Age range of 18 to75 Patients diagnosed primary breast cancer(T2-3, N0-2, M0) Patients will have elective adenomammectomy

Exclusion Criteria

* with history of breast operation Patients diagnosed carcinoma erysipelatodes Severe liver, renal, brain or lung disease with history of opioid addiction Patients diagnosed metastatic breast cancer
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jie Tian

Role: PRINCIPAL_INVESTIGATOR

RenJi Hospital

Locations

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Renji Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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Liu Y, Sun J, Wu T, Lu X, Du Y, Duan H, Yu W, Su D, Lu J, Tian J. Effects of serum from breast cancer surgery patients receiving perioperative dexmedetomidine on breast cancer cell malignancy: A prospective randomized controlled trial. Cancer Med. 2019 Dec;8(18):7603-7612. doi: 10.1002/cam4.2654. Epub 2019 Oct 30.

Reference Type DERIVED
PMID: 31663690 (View on PubMed)

Other Identifiers

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DEX201703

Identifier Type: -

Identifier Source: org_study_id