Body composition and low blood counts in breast cancer patients receiving chemotherapy

Phase 2

Recruiting

• Conditions: Patients with stage I- III breast cancerPlanned to receive adjuvant or neoadjuvant chemotherapy; Early breast cancer; (neo)adjuvant chemotherapy; Fat free mass/fat free mass index; Severe neutropenia/febrile neutropenia; Body composition; Bioelectrical Impedance Analysis (BIA)

• Registration Number: TCTR20190702004
• Lead Sponsor: Siriraj Research Fund

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-02
• Study Completion: 2020-03-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

1. Newly diagnosed with stage I, II or III breast cancer
2. Planned to receive (neo)adjuvant chemotherapy consisting of one of the following regimens: cyclophosphamide/doxorubicin (AC), docetaxel/ cyclophosphamide (TC), AC followed by paclitaxel or docetaxel, 5FU/epirubicin/cyclophosphamide (FEC) followed by docetaxel
3. Signed informed consent

Exclusion Criteria

1. Patients with automated implantable cardioverter-defibrillator (AICD), permanent pacemaker or other metallic device
2. Patients known to have pleural effusion, ascites or generalized edema

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Association of fat free mass index and severe neutropenia After completion of last cycle of chemotherapy Fat free mass measured by BIA device, CBC

Secondary Outcome Measures

Name	Time	Method
Prognostic impact of fat free mass index and severe neutropenia After completion of last cycle of chemotherapy Receiver Operating Characteristic (ROC) curve