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

29. April 2026 aktualisiert von: Vania Idelia Winantyo, Universitas Airlangga

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:

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

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

54

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Brief-ACT + Neoadjuvant Chemotherapy
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.
Verhalten: Brief Acceptance and Commitment Therapy
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.
Arzneimittel: Neoadjuvant Chemotherapy
Standard neoadjuvant chemotherapy regimen administered according to institutional protocols for locally advanced breast cancer.
Andere Namen:
  • Neoadjuvant Chemotherapy (NACT)
  • Neoadjuvant systemic therapy
Aktiver Komparator: Standard Counseling + Neoadjuvant Chemotherapy
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.
Arzneimittel: Neoadjuvant Chemotherapy
Standard neoadjuvant chemotherapy regimen administered according to institutional protocols for locally advanced breast cancer.
Andere Namen:
  • Neoadjuvant Chemotherapy (NACT)
  • Neoadjuvant systemic therapy
Verhalten: Standard Counseling
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Clinical response according to RECIST version 1.1
Zeitfenster: 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.
At the end of cycle 3 (each cycle is 21 days), prior to surgery

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in serum interleukin-6 (IL-6) level
Zeitfenster: 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)
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)
Zeitfenster: 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
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
Zeitfenster: 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)
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
Zeitfenster: Baseline (prior to intervention), and after completion of intervention, approximately 9 weeks after baseline measurement
Measured using the Perceived Stress Scale-10 (PSS-10)
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)
Zeitfenster: 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)
Baseline (prior to initiation of study intervention) and after completion of intervention (approximately 6-9 weeks after baseline)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Universitas Airlangga

Ermittler

  • Hauptermittler: Asdi Wihandono, MD, Surgical Oncologist, Universitas Airlangga

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

28. April 2026

Primärer Abschluss (Geschätzt)

1. Januar 2027

Studienabschluss (Geschätzt)

1. Januar 2027

Studienanmeldedaten

Zuerst eingereicht

23. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

29. April 2026

Zuerst gepostet (Tatsächlich)

6. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

6. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

29. April 2026

Zuletzt verifiziert

1. April 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 400.14.5.4/11991/102.9/2026

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

UNENTSCHIEDEN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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