CClinicalTrials.gg
Status unknownNCT03283345Updated Sep 18, 2017

Effect of Menstrual Cycle on Traumatic Systemic Response

An interventional study of modified radical mastectomy in Systemic Inflammatory Response Syndrome, sponsored by Kocaeli University. Status unknown. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-18.

Sponsored by Kocaeli University · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
89
Allocation
Non-randomized
Sex
Female
01

Study 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.

Read the 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

02

Conditions studied

  • Systemic Inflammatory Response Syndrome

Keywords

  • breast cancer
  • menstrual cycle
  • breast surgery
  • systemic responses to trauma
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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • female patients
  • who underwent modified radical mastectomy for breast cancer
  • who signed informed consent forms

Exclusion criteria

Exclusion Criteria:

  • For premenopausal patients taking oral contraceptives
  • for postmenopausal patients taking hormone replacement therapy.
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
89 participants (actual)

Study arms

  • Active comparator
    postmenopausal women

    postmenopausal female breast cancer patients who underwent modified radical mastectomy

    Procedure: modified radical mastectomy

  • Active comparator
    premenopausal women

    premenopausal female breast cancer patients who underwent modified radical mastectomy

    Procedure: modified radical mastectomy

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.

05

What researchers measure

Primary outcomes

  1. IL-1 and IL-6 levels

    evaluate pathophysiology of systemic responses to trauma via using IL-1 and IL-6 levels.

    Time frame: 5 month

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT03283345
Lead sponsor
Kocaeli University
Responsible party
Hayal Uzelli Şimşek (Principal investigator, Kocaeli University) — Principal investigator
First posted
Sep 14, 2017
Start date
Jun 2008
Primary completion
Nov 2018 (estimated)
Completion
Nov 2018 (estimated)
Last update
Sep 18, 2017

Study contacts

Cantürk
study director · Kocaeli University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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