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Effect of Menstrual Cycle on Traumatic Systemic Response

Primary Purpose

Systemic Inflammatory Response Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
modified radical mastectomy
Sponsored by
Kirsehir Ahi Evran University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Systemic Inflammatory Response Syndrome focused on measuring breast cancer, menstrual cycle, breast surgery, systemic responses to trauma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • female patients
  • who underwent modified radical mastectomy for breast cancer
  • who signed informed consent forms

Exclusion Criteria:

  • For premenopausal patients taking oral contraceptives
  • for postmenopausal patients taking hormone replacement therapy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    postmenopausal women

    premenopausal women

    Arm Description

    postmenopausal female breast cancer patients who underwent modified radical mastectomy

    premenopausal female breast cancer patients who underwent modified radical mastectomy

    Outcomes

    Primary Outcome Measures

    IL-1 and IL-6 levels
    evaluate pathophysiology of systemic responses to trauma via using IL-1 and IL-6 levels.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 20, 2017
    Last Updated
    September 15, 2017
    Sponsor
    Kirsehir Ahi Evran University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03283345
    Brief Title
    Effect of Menstrual Cycle on Traumatic Systemic Response
    Official Title
    ASSESSMENT OF SYSTEMIC RESPONSES TO TRAUMA IN DIFFERENT PHASES OF THE MENSTRUAL CYCLE: IN PATIENTS UNDERWENT MODIFIED RADICAL MASTECTOMY A Clinical Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2008 (Actual)
    Primary Completion Date
    November 2018 (Anticipated)
    Study Completion Date
    November 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kirsehir Ahi Evran University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    It is aimed to evaluate pathophysiology of systemic responses to trauma via using interleukin (IL) -1 and IL-6 levels and determining timing of surgery through phases of menstrual cycle.
    Detailed Description
    89 female breast cancer patient who underwent modified radical mastectomy included into study. Menstrual history and hormone levels were used to determine menstrual phase: luteal, follicular, and other. IL-1β and IL-6 levels, which are related to severeness of inflammation, were measured one day before and one day after surgery. Those are statistically analysed to show effect of timing of breast surgery on responses to trauma in postmenopausal and premenopausal women during different phases of their menstrual cycles

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Systemic Inflammatory Response Syndrome
    Keywords
    breast cancer, menstrual cycle, breast surgery, systemic responses to trauma

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    89 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    postmenopausal women
    Arm Type
    Active Comparator
    Arm Description
    postmenopausal female breast cancer patients who underwent modified radical mastectomy
    Arm Title
    premenopausal women
    Arm Type
    Active Comparator
    Arm Description
    premenopausal female breast cancer patients who underwent modified radical mastectomy
    Intervention Type
    Procedure
    Intervention Name(s)
    modified radical mastectomy
    Intervention Description
    systemic responses to trauma are compared with evaluating inflammatory cytokine levels between premenopausal and postmenopausal patient groups with different estrogen levels who underwent modified radical mastectomy.
    Primary Outcome Measure Information:
    Title
    IL-1 and IL-6 levels
    Description
    evaluate pathophysiology of systemic responses to trauma via using IL-1 and IL-6 levels.
    Time Frame
    5 month

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: female patients who underwent modified radical mastectomy for breast cancer who signed informed consent forms Exclusion Criteria: For premenopausal patients taking oral contraceptives for postmenopausal patients taking hormone replacement therapy.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Cantürk
    Organizational Affiliation
    Kirsehir Ahi Evran University
    Official's Role
    Study Director

    12. IPD Sharing Statement

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    Effect of Menstrual Cycle on Traumatic Systemic Response

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