IL-6 and IL-8 Level of Blood and Pleural Effusion During Chemotherapy in Metastatic Breast Cancer

Overview

Change of IL-6 and IL-8 level in blood and pleural effusion before and after chemotherapy correlate with the prognosis of the disease

Full Title of Study: “A Prospective Study Assessing the Correlation Between Disease Prognosis and the Level of IL-6 and IL-8 Level in Blood and Pleural Effusion Before and After Chemotherapy in Patients With Metastatic Breast Cancer”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: February 2013

Detailed Description

To assess the correlation between the disease prognosis and the level of IL-6 and IL-8 in blood and pleural effusion before and after chemotherapy in patients with metastatic breast cancer

Arms, Groups and Cohorts

  • pleural effusion
    • patients with pleural effusion

Clinical Trial Outcome Measures

Primary Measures

  • level of IL-6 and IL-8
    • Time Frame: 2 days

Participating in This Clinical Trial

Inclusion Criteria

  • Female between 18 and 70 years old; – Patients with histologic proved metastatic breast cancer; – Pleural effusion with the volume of more than 1000ml, as documented by CT, X ray or ultrasound; – There are no other diseases which cause the elevation of IL-6 or IL-8, such as cirrhosis of liver, anaphylactoid purpura, acute pancreatitis; – With at least one measurable disease according to RECIST criteria, – Normal laboratory results:ANC≥2.0×109/L,Hb≥80g/L,plt≥100×109/L,TB<UNL (<1.5 x UNL in patients with liver mets),ALT/AST< 1.5 x UNL (<2.5x UNL in patients with liver mets),AKP<5 x UNL(except bone mets),Cr<UNL; – Normal functions with heart, liver,renal and bone marrow; – Got ICF before enrollment; – Life expectancy more than 12 weeks. Exclusion Criteria:

  • Pregnant or breast-feeding women or positive serum pregnancy test; – Uncontrolled brain metastases; – No recovery from previous radiation or accepted radiation within 4 weeks before enrollment; – Participation in any investigational drug study within 4 weeks preceding treatment start; – Concurrent other malignancy at other sites or previous other cancer within the last 5 years, with the exception of adequately treated in situ carcinoma of cervix uteri or basal or squamous cell carcinoma of the skin; – Serious uncontrolled intercurrent infections; – Poor compliance.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fudan University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Xichun Hu, Principal Investigator – Fudan University
  • Overall Official(s)
    • Xichun Hu, MD.PhD, Principal Investigator, Fudan University

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