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

NCT03109990 | Completed

• 1 other identifier: DEX20161020
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• study feasibility

  recruitment and dropout rates

  from May 2015 to August 2019

Secondary Outcomes (8)

• recurrence-free survival

  up to 5 years after surgery

• overall survival

  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

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

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

saline

PLACEBO COMPARATOR

Same amount of saline will be administrated.

Drug: Saline

Interventions

Dexmedetomidine DRUG

Patients in the experimental group will receive Dexmedetomidine during surgery.

Dexmedetomidine

Saline DRUG

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

saline

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200127, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Dexmedetomidine; Sodium Chloride

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

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

Study Record Dates

• First Submitted: March 11, 2017
• First Posted: April 12, 2017
• Study Start: May 1, 2016
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: November 10, 2022

Record last verified: 2022-11

Locations

CN (1)