NCT03108937

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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 11, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

April 12, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2017

Completed
Last Updated

October 10, 2017

Status Verified

March 1, 2017

Enrollment Period

3 months

First QC Date

April 6, 2017

Last Update Submit

October 8, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • cell proliferation

    MCF-7 cells will be cultured with serum from patients of both groups for 24 hours and cell proliferation will be measured

    24 hour post-surgery

Secondary Outcomes (2)

  • cell migration

    24 hour post-surgery

  • cell metastasis

    24 hour post-surgery

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

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.

Drug: Dexmedetomidine

saline

PLACEBO COMPARATOR

Same amount of saline will be administrated.

Drug: saline

Interventions

Patients in the experimental group will receive Dexmedetomidine during surgery.

Dexmedetomidine
salineDRUG

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

saline

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Breast Neoplasms

Interventions

DexmedetomidineSodium Chloride

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Jie Tian

    RenJi Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2017

First Posted

April 11, 2017

Study Start

April 12, 2017

Primary Completion

July 7, 2017

Study Completion

September 8, 2017

Last Updated

October 10, 2017

Record last verified: 2017-03

Locations