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NCT Number: NCT03109990

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Renji hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200127, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

Patients in the experimental group will receive Dexmedetomidine during surgery.

Saline

Drug

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

Primary outcomes

  1. study feasibility

    Time frame: from May 2015 to August 2019

    recruitment and dropout rates

Secondary outcomes

  1. recurrence-free survival

    Time frame: up to 5 years after surgery

    time from surgery to the earliest date of recurrence/metastasis

  2. overall survival

    Time frame: up to 5 years after surgery

    time from surgery to the date of all-cause death

  3. the number of blood CD3+ cells

    Time frame: at 24 hours after surgery

  4. the number/percentage of blood CD4+ cells

    Time frame: at 24 hours after surgery

  5. the number/percentage of blood CD8+ cells

    Time frame: at 24 hours after surgery

  6. the number/percentage of blood NK cells

    Time frame: at 24 hours after surgery

  7. the ratio of CD4+ cells / CD8+ cells

    Time frame: at 24 hours after surgery

  8. the number/percentage of blood CD19+ cells

    Time frame: at 24 hours after surgery

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Apr 12, 2017
Registry last updated
Nov 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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