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Effect of Menstrual Cycle on Traumatic Systemic Response

NCT ID: NCT03283345

Last Updated: 2017-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2018-11-30

Brief Summary

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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

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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

Conditions

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Systemic Inflammatory Response Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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postmenopausal women

postmenopausal female breast cancer patients who underwent modified radical mastectomy

Group Type ACTIVE_COMPARATOR

modified radical mastectomy

Intervention Type PROCEDURE

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.

premenopausal women

premenopausal female breast cancer patients who underwent modified radical mastectomy

Group Type ACTIVE_COMPARATOR

modified radical mastectomy

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Kocaeli University

OTHER

Sponsor Role lead

Responsible Party

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Hayal Uzelli Şimşek

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cantürk

Role: STUDY_DIRECTOR

Kocaeli University

Other Identifiers

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2008/69

Identifier Type: -

Identifier Source: org_study_id