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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-65
SponsorUniversitas Airlangga

About this trial

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

Eligibility criteria

Qualifiers

Female patients aged 40-65 years

Histologically confirmed locally advanced breast cancer

Planned to undergo neoadjuvant chemotherapy

ECOG performance status 0-2

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Brief Acceptance and Commitment Therapy
  • Standard Counseling
  • Neoadjuvant Chemotherapy

Treatment groups

54 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators