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NCT Number: NCT07570368

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

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

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Key information

Conditions

Breast Cancer Behavior Behavioral Symptoms Breast Diseases Breast Neoplasm Female Breast Neoplasms Locally Advanced Breast Cancer Locally Advanced Breast Cancer (LABC) Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Stress, Psychological

Age range

40 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

Breast cancer patients with locally advanced disease frequently experience substantial psychological distress during treatment, which has been associated with adverse biological effects. Chronic psychological stress may activate neuroendocrine pathways, particularly the hypothalamic-pituitary-adrenal (HPA) axis, leading to increased production of pro-inflammatory cytokines and angiogenic factors. These biological alterations, including elevated levels of interleukin-6 (IL-6), C-reactive protein (CRP), neutrophil-to-lymphocyte ratio (NLR), and vascular endothelial growth factor (VEGF), are thought to contribute to tumor progression and resistance to chemotherapy.

Emerging evidence suggests that psychological interventions may influence these biological pathways. Acceptance and Commitment Therapy (ACT), particularly in its brief format (Brief-ACT), has been shown to improve psychological flexibility and reduce stress. However, its potential role in modulating inflammatory and angiogenic biomarkers and improving chemotherapy response in breast cancer patients remains insufficiently explored.

This study is designed as a randomized controlled trial to evaluate the effect of Brief-ACT on treatment response in patients with locally advanced breast cancer undergoing neoadjuvant chemotherapy. The intervention is delivered alongside standard chemotherapy and focuses on enhancing psychological flexibility through core ACT processes, including acceptance, cognitive defusion, present-moment awareness, and value-based action.

In addition to evaluating clinical response, this study investigates the potential biological mechanisms underlying the effect of psychological intervention. Serial measurements of inflammatory and angiogenic biomarkers are performed to assess whether changes in psychological stress are associated with modulation of these pathways. This integrative approach aims to bridge psychological and biological domains in cancer treatment.

The findings of this study are expected to provide evidence on whether a structured psychological intervention can serve as an adjunctive strategy to improve chemotherapy outcomes through modulation of stress-related biological processes. If effective, this approach may support the integration of psychosocial care into standard oncological treatment to enhance both clinical and biological outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Neoadjuvant chemotherapy

Drug

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

Other names: Neoadjuvant Chemotherapy (NACT), Neoadjuvant systemic therapy

Primary outcomes

  1. Clinical response according to RECIST version 1.1

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

    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.

Secondary outcomes

  1. Change in serum interleukin-6 (IL-6) level

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

    Measured in pg/mL using enzyme-linked immunosorbent assay (ELISA)

  2. Change in neutrophil-to-lymphocyte ratio (NLR)

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

    Calculated from complete blood count parameters

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

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

    Measured in pg/mL using enzyme-linked immunosorbent assay (ELISA)

  4. Change in perceived stress level

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

    Measured using the Perceived Stress Scale-10 (PSS-10)

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

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

    Measured using the Acceptance and Action Questionnaire-II (AAQ-II), a self-reported instrument assessing psychological flexibility. Scores typically range from 7 to 49, with higher scores indicating greater psychological inflexibility (lower psychological flexibility)

Study contacts

Contact information is provided by the study sponsor or research team.

Vania Idelia Winantyo, MD, General Surgeon

CONTACT

[email protected]

+6281906000050

Sponsors and collaborators

Lead sponsor

Universitas Airlangga

Other

Registry information

Official study title

Effect of Brief Acceptance and Commitment Therapy on Neoadjuvant Chemotherapy Response in Locally Advanced Breast Cancer Through Modulation of Inflammatory and Angiogenic Biomarkers.

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 6, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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