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.
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
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Vania Idelia Winantyo, MD, General Surgeon
- 電話番号：+6281906000050
- メール：vania.winantyo@gmail.com
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
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 neoadjuvant chemotherapy regimen administered according to institutional protocols for locally advanced breast cancer.
他の名前：
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アクティブコンパレータ：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.
|
Standard neoadjuvant chemotherapy regimen administered according to institutional protocols for locally advanced breast cancer.
他の名前：
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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Clinical response according to RECIST version 1.1
時間枠：At the end of cycle 3 (each cycle is 21 days), prior to surgery
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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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in serum interleukin-6 (IL-6) level
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
|
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Change in psychological flexibility measured by Acceptance and Action Questionnaire-II (AAQ-II)
時間枠：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)
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Asdi Wihandono, MD, Surgical Oncologist、Universitas Airlangga
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 400.14.5.4/11991/102.9/2026
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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