Effect of Menstrual Cycle on Traumatic Systemic Response

Study Overview
=================
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

Official Title
-----------------
ASSESSMENT OF SYSTEMIC RESPONSES TO TRAUMA IN DIFFERENT PHASES OF THE MENSTRUAL CYCLE: IN PATIENTS UNDERWENT MODIFIED RADICAL MASTECTOMY A Clinical Study

Conditions
-----------------
Systemic Inflammatory Response Syndrome

Intervention / Treatment
-----------------
* Procedure: modified radical mastectomy


Participation Criteria
=================
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.
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: postmenopausal women<br>postmenopausal female breast cancer patients who underwent modified radical mastectomy | Procedure: modified radical mastectomy<br>* 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.<br>|
| Active Comparator: premenopausal women<br>premenopausal female breast cancer patients who underwent modified radical mastectomy | Procedure: modified radical mastectomy<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IL-1 and IL-6 levels | evaluate pathophysiology of systemic responses to trauma via using IL-1 and IL-6 levels. | 5 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer, menstrual cycle, breast surgery, systemic responses to trauma