The Association of Psychological Stress with the Efficacy of Neoadjuvant Therapy in Breast Cancer
ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorShengjing Hospital
About this trial
This study aims to explore the relationship between psychological stress and the therapeutic response in breast cancer patients who have received standard neoadjuvant chemotherapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
1. Breast cancer has not been confirmed through histological or cytological examinations.
Trial population
The participants included patients diagnosed with breast cancer who were about to receive neoadjuvant therapy.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Exposure: psychological stress status
Other interventionThe assessment of depressive, anxiety or perceived Stress was conducted using PHQ-9, GAD-7 or PSS scale. Patients with a PHQ-9 score ≥ 5 or a GAD-7 score ≥ 5 or a PSS score ≥ 20 were categorized as the stressed group.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Pathologic complete response (pCR) rate
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.
Time frame
2 yearsSecondary outcomes
1
Quality of life
Quality of Life (QoL) is assessed using the Functional Assessment of Cancer Therapy-Breast (FACT-B, Version 4.0).
Time frame
2 years2
peripheral stress biomarkers
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.
Time frame
2 years3
Objective Response Rate (ORR)
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.
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov