Clinical trial NCT06690645: The Association of Psychological Stress with the Efficacy of Neoadjuvant Therapy in Breast Cancer
Official title: The Association of Psychological Stress with the Efficacy of Neoadjuvant Therapy in Breast Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Keywords: psychological stress, breast cancer
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2024-11-15
Enrollment: 840
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participants included patients diagnosed with breast cancer who were about to receive neoadjuvant therapy.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pathologic complete response (pCR) rate
timeFrame: 2 years
Secondary outcomes:
measure: Quality of life
timeFrame: 2 years
measure: peripheral stress biomarkers
timeFrame: 2 years
measure: Objective Response Rate (ORR)
timeFrame: 2 years
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
Study officials:
References: