Effect of Menstrual Cycle on Traumatic Systemic Response

Kocaeli University

Status: Unknown

Conditions: Systemic Inflammatory Response Syndrome

Treatments: Procedure: modified radical mastectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03283345

2008/69

Details and patient eligibility

About

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.

Full 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

Enrollment: 89 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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89 participants in 2 patient groups

postmenopausal women

Active Comparator group

Description:

postmenopausal female breast cancer patients who underwent modified radical mastectomy

Treatment:

Procedure: modified radical mastectomy

premenopausal women

Active Comparator group

Description:

premenopausal female breast cancer patients who underwent modified radical mastectomy

Treatment:

Procedure: modified radical mastectomy