Targeting Stress-Driven Inflammatory and Angiogenic Pathways With Brief ACT to Enhance Neoadjuvant Chemotherapy Response in Locally Advanced Breast Cancer

Starting soon · Not applicable

Conditions studied: Breast Cancer, Breast Neoplasm Female, Locally Advanced Breast Cancer (LABC), Locally Advanced Breast Cancer

In brief

This clinical trial aims to learn whether a brief psychological therapy called Brief Acceptance and Commitment Therapy (Brief-ACT) can improve the effectiveness of neoadjuvant chemotherapy in patients with locally advanced breast cancer. It will also examine how this therapy affects stress levels and certain blood markers related to inflammation and tumor growth. The main questions this study aims to answer are: Does Brief-ACT improve the rate of pathological complete response (pCR) after chemotherapy? Does Brief-ACT reduce levels of inflammatory and angiogenic biomarkers such as C-reactive protein (CRP), interleukin-6 (IL-6), neutrophil-to-lymphocyte ratio (NLR), and vascular endothelial growth factor (VEGF)? Does Brief-ACT reduce psychological stress in patients undergoing chemotherapy? Researchers will compare patients who receive Brief-ACT in addition to standard chemotherapy with those who receive standard chemotherapy alone to see if there are differences in treatment response, stress levels, and biomarker levels. Participants will: Receive neoadjuvant chemotherapy according to standard treatment protocols Be assigned to receive Brief-ACT sessions or no additional psychological intervention Attend regular clinic visits for treatment and monitoring Provide blood samples at specific time points for laboratory analysis Complete questionnaires to assess psychological stress

Key facts

Study ID

NCT07570368

Run by

Universitas Airlangga

People needed

54

Starts

2026-04-28

Expected to finish

2027-01-01

Last updated by the study team

2026-05-06

Who can join

Age: 40 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female patients aged 40-65 years
• Histologically confirmed locally advanced breast cancer
• Planned to undergo neoadjuvant chemotherapy
• ECOG performance status 0-2
• Able to provide informed consent
• Willing to participate in psychological intervention sessions

You may not qualify if…

• Severe psychological distress defined as Perceived Stress Scale (PSS-10) score ≥27
• Active infection or inflammatory disease
• Known autoimmune disease
• Cognitive impairment or psychiatric condition interfering with participation
• Concurrent participation in another interventional study

Full record on ClinicalTrials.gov

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