Muscle Parameters and Pathological Response in Breast Cancer Patients

Neoadjuvant Chemotherapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06151379
• Other study ID #: AcibademAH
• Status: Completed
• Start date: March 1, 2023
• Est. completion date: October 20, 2023

Study information

• Verified date: November 2023
• Source: Acibadem Atunizade Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: October 20, 2023
• Est. primary completion date: September 30, 2023
• Gender: Female
• Age group: 29 Years to 72 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neoadjuvant Chemotherapy

Intervention

Other:
• Neoadjuvant therapy
To measure muscle mass and predict pCR to NAC and its effect on clinical outcomes.

Locations

Country	Name	City	State
Turkey	AcibademAH	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Acibadem Atunizade Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Residual cancer burden	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.
Primary	Sarcopenic index	skeletal muscle area (cm2)/height (m2) et L3 level	Through study completion, an average of 1 year.
Secondary	Body mass index	weight (kg)/height (m2)	Through study completion, an average of 1 year.