Effect of Menstrual Cycle on Traumatic Systemic Response

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

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.

Study Overview

• Status: Unknown
• Conditions: Systemic Inflammatory Response Syndrome
• Intervention / Treatment: Procedure: modified radical mastectomy

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
• Enrollment (Actual): 89
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

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

Collaborators and Investigators

• Sponsor: Kocaeli University
• Investigators: Study Director: Cantürk, Kocaeli University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2008
• Primary Completion (Anticipated): November 1, 2018
• Study Completion (Anticipated): November 1, 2018

Study Registration Dates

• First Submitted: August 20, 2017
• First Submitted That Met QC Criteria: September 12, 2017
• First Posted (Actual): September 14, 2017

Study Record Updates

• Last Update Posted (Actual): September 18, 2017
• Last Update Submitted That Met QC Criteria: September 15, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: menstrual cycle; breast cancer; breast surgery; systemic responses to trauma
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Shock; Systemic Inflammatory Response Syndrome
• Other Study ID Numbers: 2008/69

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No