AzTrials
AzTrials

Breast CancerNCT07570368

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

A study testing Brief Acceptance and Commitment Therapy, Standard Counseling and Neoadjuvant Chemotherapy in people with Breast Cancer and Breast Neoplasm Female, run by Universitas Airlangga.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 to 65 years, women only
What is being tested?
Brief Acceptance and Commitment Therapy, Standard Counseling and Neoadjuvant Chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
No sites listed yet
Study dates
28 Apr 2026to Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Vania Idelia Winantyo, MD, General Surgeon contact

+6281906000050

vania.winantyo@gmail.com

About this study

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

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:

Read more

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

Read the detailed description

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.

Being tested
Brief Acceptance and Commitment Therapy, Standard Counseling, Neoadjuvant Chemotherapy
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
Medical subject headings
Breast Neoplasms, Stress, Psychological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brief Acceptance and Commitment TherapyBehavioural

    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 CounselingBehavioural

    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 ChemotherapyDrug

    Also called Neoadjuvant Chemotherapy (NACT), Neoadjuvant systemic therapy

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

Study groups in NCT07570368
Study groupRoleWhat they receive
Brief-ACT + Neoadjuvant ChemotherapyExperimentalParticipants 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.
Receives: Behavioral: Brief Acceptance and Commitment Therapy; Drug: Neoadjuvant Chemotherapy
Standard Counseling + Neoadjuvant ChemotherapyActive comparatorParticipants 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.
Receives: Behavioral: Standard Counseling; Drug: Neoadjuvant Chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (5)
  1. Change in serum interleukin-6 (IL-6) level

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

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

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

    Calculated from complete blood count parameters

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

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

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

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

  4. Change in perceived stress level

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

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

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

    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)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2026
  2. Study start28 Apr 2026 (estimated)
  3. Primary completionJan 2027 (estimated)
  4. Study completionJan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07570368
Sponsor's protocol ID
400.14.5.4/11991/102.9/2026
Status last verified
Apr 2026
First submitted
23 Apr 2026
Last updated
6 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Data sharing plans are currently under consideration. The study team intends to evaluate data sharing options following completion of the study and publication of the primary results, taking into account institutional policies, ethical considerations, and participant confidentiality.

Questions about this trial

What is this clinical trial studying?

A study testing Brief Acceptance and Commitment Therapy, Standard Counseling and Neoadjuvant Chemotherapy in people with Breast Cancer and Breast Neoplasm Female, run by Universitas Airlangga.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Vania Idelia Winantyo, MD, General Surgeon (+6281906000050, vania.winantyo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical response according to RECIST version 1.1 (time frame: At the end of cycle 3 (each cycle is 21 days), prior to surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Clinical Trial NCT07570368 | AzTrials