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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03283345
Enrollment
89
Registered
2017-09-14
Start date
2008-06-30
Completion date
2018-11-30
Last updated
2017-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Inflammatory Response Syndrome

Keywords

breast cancer, menstrual cycle, breast surgery, systemic responses to trauma

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

Interventions

PROCEDUREmodified 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.

Sponsors

Kocaeli University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
IL-1 and IL-6 levels5 monthevaluate pathophysiology of systemic responses to trauma via using IL-1 and IL-6 levels.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026