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

NCT07570368 | Not Yet Recruiting

• 1 other identifier: 400.14.5.4/11991/102.9/2026
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Breast Cancer; Breast Neoplasm Female; Locally Advanced Breast Cancer (LABC); Locally Advanced Breast Cancer

Keywords

breast cancer; Locally advanced breast cancer; brief acceptance and commitment therapy; acceptance and commitment therapy; neoadjuvant chemotherapy; clinical chemotherapy response; inflammatory biomarkers; angiogenic biomarkers; interleukin-6; neutrophil to lymphocyte ratio; vascular endothelial growth factor; psychological stress; psycho-oncology

Outcome Measures

Primary Outcomes (1)

• Clinical response according to RECIST version 1.1

  Clinical response will be assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 based on radiologic tumor evaluation. Responses will be categorized as complete response, partial response, stable disease, or progressive disease according to RECIST 1.1 criteria.

  At the end of cycle 3 (each cycle is 21 days), prior to surgery

Secondary Outcomes (5)

• Change in serum interleukin-6 (IL-6) level

  Baseline (prior to initiation of chemotherapy) and after completion of cycle 3 chemotherapy (approximately 9 weeks, each cycle is 21 days)

• Change in neutrophil-to-lymphocyte ratio (NLR)

  Baseline (prior to initiation of chemotherapy) and after completion of cycle 3 chemotherapy (approximately 9 weeks, each cycle is 21 days)

• Change in serum vascular endothelial growth factor A (VEGF-A) level

  Baseline (prior to initiation of chemotherapy) and after completion of cycle 3 chemotherapy (approximately 9 weeks, each cycle is 21 days)

• Change in perceived stress level

  Baseline (prior to intervention), and after completion of intervention, approximately 9 weeks after baseline measurement

• Change in psychological flexibility measured by Acceptance and Action Questionnaire-II (AAQ-II)

  Baseline (prior to initiation of study intervention) and after completion of intervention (approximately 6-9 weeks after baseline)

Study Arms (2)

Brief-ACT + Neoadjuvant Chemotherapy

EXPERIMENTAL

Participants in this arm receive standard neoadjuvant chemotherapy in combination with Brief Acceptance and Commitment Therapy (Brief-ACT). The Brief-ACT intervention is delivered in structured sessions during the course of chemotherapy and focuses on enhancing psychological flexibility through core ACT processes, including acceptance, cognitive defusion, present-moment awareness, and value-based action.

Behavioral: Brief Acceptance and Commitment Therapy; Drug: Neoadjuvant Chemotherapy

Standard Counseling + Neoadjuvant Chemotherapy

ACTIVE COMPARATOR

Participants in this arm receive standard neoadjuvant chemotherapy along with standard counseling provided as part of routine clinical care. The counseling serves as an attention-control condition to account for non-specific therapeutic effects, without incorporating structured Brief-ACT components.

Behavioral: Standard Counseling; Drug: Neoadjuvant Chemotherapy

Interventions

Brief Acceptance and Commitment Therapy BEHAVIORAL

Brief Acceptance and Commitment Therapy (Brief-ACT) is a structured psychological intervention delivered during the course of neoadjuvant chemotherapy. The intervention focuses on enhancing psychological flexibility through core ACT processes, including acceptance, cognitive defusion, present-moment awareness, self-as-context, values clarification, and committed action. Sessions are delivered in a brief format tailored to the clinical setting and are integrated into routine oncology care during chemotherapy cycles.

Brief-ACT + Neoadjuvant Chemotherapy

Standard Counseling BEHAVIORAL

Standard counseling consists of routine supportive communication provided as part of standard clinical care during neoadjuvant chemotherapy. This includes general emotional support, basic health education, and non-directive discussion without the use of structured psychotherapeutic techniques such as Acceptance and Commitment Therapy. This intervention serves as an attention-control condition.

Standard Counseling + Neoadjuvant Chemotherapy

Neoadjuvant Chemotherapy DRUG

Standard neoadjuvant chemotherapy regimen administered according to institutional protocols for locally advanced breast cancer.

Also known as: Neoadjuvant Chemotherapy (NACT), Neoadjuvant systemic therapy

Brief-ACT + Neoadjuvant Chemotherapy; Standard Counseling + Neoadjuvant Chemotherapy

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Universitas Airlangga: lead

MeSH Terms

Conditions

Breast Neoplasms; Stress, Psychological

Interventions

Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Study Officials

• Asdi Wihandono, MD, Surgical Oncologist

  Universitas Airlangga

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vania Idelia Winantyo, MD, General Surgeon

CONTACT

+6281906000050; vania.winantyo@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants are not informed of the specific study hypothesis or group allocation and receive either Brief Acceptance and Commitment Therapy (Brief-ACT) or standard counseling as part of the intervention. Outcome assessors evaluating treatment response are blinded to group assignment. Care providers delivering the psychological interventions are not blinded due to the nature of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgeon

Model Details: This study is a randomized, parallel-group clinical trial in which participants with locally advanced breast cancer are assigned to one of two groups: (1) standard neoadjuvant chemotherapy plus Brief Acceptance and Commitment Therapy (Brief-ACT), or (2) standard neoadjuvant chemotherapy alone. Randomization is performed to ensure balanced allocation between groups. The intervention is delivered concurrently with chemotherapy without crossover between groups.

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: May 6, 2026
• Study Start: April 28, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04