The Association of Psychological Stress with the Efficacy of Neoadjuvant Therapy in Breast Cancer

Recruiting

• Conditions: Breast Cancer

• Registration Number: NCT06690645
• Lead Sponsor: Shengjing Hospital

Brief Summary

This study aims to explore the relationship between psychological stress and the therapeutic response in breast cancer patients who have received standard neoadjuvant chemotherapy.

Detailed Description

Breast cancer is the most common malignant tumor among women. Approximately 19% to 30% of patients with breast cancer achieve a pathological complete response (pCR) following neoadjuvant therapy, while about 5% to 20% of patients experience disease progression. Increasing evidence suggests the significant role of psychological factors in influencing cancer treatment outcomes. Cancer patients often experience emotional distress, including fear of relapse, anxiety, depression, and low self-esteem, which may persist for many years. Statistics indicate that the incidence of anxiety and depression among cancer patients is 49.69% and 54.90%, respectively, significantly higher than that of healthy individuals (anxiety: 18.37%, depression: 17.50%) in China. There are indications that emotional issues may be linked to cancer treatment, although the underlying mechanisms remain unclear.

This study aims to investigate the relationship between anxiety and depression and the effectiveness of standard neoadjuvant therapy in patients with breast cancer.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-11-13
• Study First Submitted QC: 2024-11-13
• Last Update Submitted: 2024-11-13
• Study Start: 2024-11-15
• Study First Posted: 2024-11-15
• Last Update Posted: 2024-11-15
• Primary Completion: 2026-08-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 840

Inclusion Criteria

• 1.Age ≥ 18 years; 2.Histological and/or cytological diagnosis of breast cancer; 3.Treatment niave patients; 4.To receive standard neoadjuvant therapy; 5.Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 6.Presence of at least one measurable lesion according to the Response Evaluation Criteria in Advanced Solid Tumors version 1.1 (RECIST v1.1) ; 7.Informed and agreed to participate in the study;

Exclusion Criteria

• 1. Breast cancer has not been confirmed through histological or cytological examinations.

  2.Other breast cancer conditions that do not receive neoadjuvant therapy. 3.Combined with other malignant tumors. 4.Concurrent acute or chronic psychiatric disorders, along with having received antidepressant or anti-anxiety therapy within the past month.

  5.Participants must not have engaged in any other clinical trials in the past month, unless those trials are observational or non-interventional in nature.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pathologic complete response (pCR) rate	2 years	pCR is defined as the absence of viable tumor cells in both the tumor bed and lymph nodes. The pCR rate refers to the percentage of patients who achieve this complete response.

Secondary Outcome Measures

Name	Time	Method
Quality of life	2 years	Quality of Life (QoL) is assessed using the Functional Assessment of Cancer Therapy-Breast (FACT-B, Version 4.0).
peripheral stress biomarkers	2 years	The stress biomarkers, including cortisol and adrenocorticotropic hormone (ACTH), were measured to evaluate the association between peripheral stress biomarkers and the efficacy of neoadjuvant therapy.
Objective Response Rate (ORR)	2 years	The objective response rate refers to the proportion of patients whose tumor volume has decreased to a predetermined value and who can maintain that reduction for the minimum required duration.

Trial Locations

Locations (1)

Shengjing Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China