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Effect of Menstrual Cycle on Traumatic Systemic Response

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ClinicalTrials.gov Identifier: NCT03283345
Recruitment Status : Active, not recruiting
First Posted : September 14, 2017
Last Update Posted : September 18, 2017
Sponsor:
Information provided by (Responsible Party):
Hayal Uzelli Şimşek, Kocaeli University

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.

Condition or disease Intervention/treatment Phase
Systemic Inflammatory Response Syndrome Procedure: modified radical mastectomy Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: ASSESSMENT OF SYSTEMIC RESPONSES TO TRAUMA IN DIFFERENT PHASES OF THE MENSTRUAL CYCLE: IN PATIENTS UNDERWENT MODIFIED RADICAL MASTECTOMY A Clinical Study
Actual Study Start Date : June 2008
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: postmenopausal women
postmenopausal female breast cancer patients who underwent modified radical mastectomy
Procedure: modified radical mastectomy
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.

Active Comparator: premenopausal women
premenopausal female breast cancer patients who underwent modified radical mastectomy
Procedure: modified radical mastectomy
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 Measures :
  1. IL-1 and IL-6 levels [ Time Frame: 5 month ]
    evaluate pathophysiology of systemic responses to trauma via using IL-1 and IL-6 levels.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03283345


Sponsors and Collaborators
Kocaeli University
Investigators
Study Director: Cantürk Kocaeli University

Responsible Party: Hayal Uzelli Şimşek, Principal investigator, Kocaeli University
ClinicalTrials.gov Identifier: NCT03283345     History of Changes
Other Study ID Numbers: 2008/69
First Posted: September 14, 2017    Key Record Dates
Last Update Posted: September 18, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hayal Uzelli Şimşek, Kocaeli University:
breast cancer
menstrual cycle
breast surgery
systemic responses to trauma

Additional relevant MeSH terms:
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock