NCT07570368Not yet recruiting
Targeting Stress-Driven Inflammatory and Angiogenic Pathways With Brief ACT to Enhance Neoadjuvant Chemotherapy Response in Locally Advanced Breast Cancer
Effect of Brief Acceptance and Commitment Therapy on Neoadjuvant Chemotherapy Response in Locally Advanced Breast Cancer Through Modulation of Inflammatory and Angiogenic Biomarkers.
Source: ClinicalTrials.gov · Last updated 6 May 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 54 (estimated)
- First submitted
- 23 Apr 2026
- Start date
- 28 Apr 2026
- Primary completion date
- 31 Jan 2027
- Lead sponsor
- Universitas Airlangga
- Diseases
- Metastatic breast cancer
- NCT number
- NCT07570368
What you commit to
- Study type: Interventional
- Planned participants: 54
- From 28 Apr 2026 to the primary completion date, 31 Jan 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent participation in another interventional study
Other illness
- Active infection or inflammatory disease
- Known autoimmune disease
- Cognitive impairment or psychiatric condition interfering with participation
Other
- Severe psychological distress defined as Perceived Stress Scale (PSS-10) score ≥27
Who the study is looking for
- 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
Age in the registry: 40 years to 65 years · Sex: Female · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.