Muscle Parameters and Pathological Response in Breast Cancer Patients

November 21, 2023 updated by: Ebru Yilmaz, Acıbadem Atunizade Hospital

The Relation Between the Initial Value of the Skeletal Mass Index and Pathological Response

The investigators aimed to accurately measure muscle mass and predict pCR to NAC and its effect on clinical outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In patients with operable breast cancer (BC) receiving neoadjuvant chemotherapy (NAC), the pathological response rate was found to be related to body composition. The success of complete pathologic response (pCR) is a known prognostic factor in BC patients treated with NAC. The investigators aimed to accurately measure muscle mass and predict pCR to NAC and its effect on clinical outcomes.

Study Type

Observational

Enrollment (Actual)

69

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34782
        • AcıbademAH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Early and locally advanced operated breast cancer patients receiving neoadjuvant chemotherapy.

Description

Inclusion Criteria:

  • Early and locally advanced operated breast cancer patients receiving neoadjuvant chemotherapy.

Exclusion Criteria:

  • Patients who did not receive neoadjuvant chemotherapy, had metastatic breast cancer and whose radiological images were not available.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pathologic complete response (pCR)
Patient with complete pathological response
Other: Neoadjuvant therapy
To measure muscle mass and predict pCR to NAC and its effect on clinical outcomes.
Pathologic incomplete response (non-pCR)
Patient with partial pathological response
Other: Neoadjuvant therapy
To measure muscle mass and predict pCR to NAC and its effect on clinical outcomes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sarcopenic index
Time Frame: Through study completion, an average of 1 year.
skeletal muscle area (cm2)/height (m2) et L3 level
Through study completion, an average of 1 year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body mass index
Time Frame: Through study completion, an average of 1 year.
weight (kg)/height (m2)
Through study completion, an average of 1 year.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Residual cancer burden
Time Frame: Through study completion, an average of 1 year.
Residual cancer burden (RCB) is estimated from routine pathologic sections of the primary breast tumor site and the regional lymph nodes after the completion of neoadjuvant therapy.
Through study completion, an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acıbadem Atunizade Hospital

Investigators

  • Principal Investigator: Aysun Isiklar, M.D., Acıbadem Atunizade Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Actual)

September 30, 2023

Study Completion (Actual)

October 20, 2023

Study Registration Dates

First Submitted

November 4, 2023

First Submitted That Met QC Criteria

November 21, 2023

First Posted (Actual)

November 30, 2023

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 21, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AcıbademAH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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