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Five-Element Music Therapy for Psychological Distress in Pancreatic Cancer Chemotherapy (FEMT-PC)

2026年9月11日 更新者：Tianjin Medical University Cancer Institute and Hospital

Effect of Ziwu Liuzhu Five-Element Music Therapy on Psychological Distress in Patients With Pancreatic Cancer Undergoing Chemotherapy: A Multicenter, Non-Inferiority Randomized Controlled Trial

Ziwu Liuzhu Five-Element Music Therapy is a non-pharmacological intervention grounded in the traditional Chinese medicine theory of "five tones corresponding to the five viscera and five emotions," integrated with the chronomedicine framework of Ziwu Liuzhu (midnight-noon meridian flow). It delivers specific musical modes at designated two-hour intervals to resonate with meridian qi and blood, achieving the therapeutic goals of "time-matched music for organ-specific regulation." Existing meta-analyses have confirmed that five-element music therapy significantly alleviates anxiety and depression and improves quality of life in cancer patients; however, no dedicated study has been conducted in pancreatic cancer patients undergoing chemotherapy.

This is a multicenter, prospective, parallel-group, non-inferiority randomized controlled trial. A total of 320 pancreatic cancer patients with mild-to-moderate anxiety receiving NALIRIFOX or AG (nab-paclitaxel + gemcitabine) chemotherapy will be enrolled and randomly assigned in a 1:1 ratio to either the Ziwu Liuzhu Five-Element Music Therapy group or the Mindfulness-Based Stress Reduction (MBSR) group. The intervention group receives 20-minute sessions, three times daily, for 8 weeks of Ziwu Liuzhu Five-Element Music listening. The control group receives an 8-week standard MBSR program consisting of twice-daily home practice and weekly online group sessions.

The primary outcome is the change in HADS-Anxiety score from baseline to week 8. Secondary outcomes include depression (HADS-D), quality of life (EORTC QLQ-C30), and biomarkers (NLR, MLR, albumin, etc.). This trial aims to demonstrate that Ziwu Liuzhu Five-Element Music Therapy is non-inferior to a standardized psychological intervention (MBSR) for improving Psychological Distress in pancreatic cancer patients during chemotherapy.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

Background Pancreatic cancer patients have a high prevalence of anxiety and depression, with rates reaching 70% for depression and 80% for anxiety after diagnosis; however, 73% of those with Psychological Distress do not receive effective intervention. Psychological Distress promotes pancreatic cancer progression through sympathetic-exosome pathways, establishing an "emotion-tumor" vicious cycle. Although the NALIRIFOX or AG regimen extends survival, the incidence of grade ≥3 adverse events reaches 73.1%, and chemotherapy toxicities interact bidirectionally with Psychological Distress. Music therapy has been recommended by NCCN and other guidelines for improving Psychological Distress in cancer patients. Ziwu Liuzhu Five-Element Music Therapy integrates five-element music with chronomedicine, delivering music at specific time periods to enhance therapeutic efficacy; however, high-level evidence is lacking for pancreatic cancer patients undergoing chemotherapy.

Study Objectives This study aims to: (1) demonstrate that Ziwu Liuzhu Five-Element Music Therapy is non-inferior to Mindfulness-Based Stress Reduction in reducing anxiety in pancreatic cancer patients during chemotherapy; (2) evaluate its effects on depression, quality of life, and biomarkers.

Study Design This is a multicenter, prospective, parallel-group, non-inferiority randomized controlled trial with a 1:1 allocation ratio to either the Ziwu Liuzhu Five-Element Music Therapy group or the MBSR group.

Participants Inclusion criteria: age ≥18 years; histologically confirmed pancreatic cancer; first-line chemotherapy with NALIRIFOX or AG (nab-paclitaxel + gemcitabine) regimen; ECOG PS ≤2; life expectancy >3 months; HAMA score 7-23 (mild-to-moderate anxiety); voluntary signed informed consent. A total of 320 participants (160 per group) are planned for enrollment.

Exclusion criteria: severe psychiatric disorders, cognitive impairment, suicidal ideation, or unstable antipsychotic medication dosage; chemotherapy-related acute unstable conditions; severe hearing impairment or intolerance to music; concurrent participation in other clinical trials; regular mindfulness or yoga practice history (≥2 times/week for ≥3 months).

Intervention

The intervention group receives an 8-week Ziwu Liuzhu Five-Element Music Therapy program:

Si Period (9:00-11:00, Spleen meridian): Gong mode (e.g., "Spring River Moonlight"), 20 minutes after breakfast, once daily, 20 minutes per session.

Wu Period (11:00-13:00, Heart meridian): Zhi mode (e.g., "Purple Bamboo Tune"), before lunchtime rest, once daily, 20 minutes per session.

You Period (17:00-19:00, Kidney meridian): Yu mode (e.g., "Three Variations of Plum Blossom"), during dinner, once daily, 20 minutes per session.

During hospitalization, bedside guidance is provided by the responsible nurse. At home, exercises are supervised via video, with daily check-in recording.

The control group receives an 8-week standard Mindfulness-Based Stress Reduction program: weekly online group sessions (60 minutes/session) + twice-daily home audio-guided practice (20 minutes/session)..

Outcome Measures Primary outcome: HADS-Anxiety score (T0, T1, T2). Secondary outcomes: HADS-Depression score, EORTC QLQ-C30 quality of life score (T0, T1, T2).

Exploratory outcomes: NLR, MLR, albumin, total protein, hemoglobin, glucose (prior to each chemotherapy cycle).

Statistical Analysis Non-inferiority testing with one-sided α = 0.025. Linear mixed-effects models are used to analyze HADS-A change scores. Non-inferiority is claimed if the upper bound of the 97.5% confidence interval for the between-group difference is less than the prespecified non-inferiority margin (1.225 points). Intention-to-treat analysis is primary; per-protocol analysis is sensitivity.

Ethics and Registration This study has been approved by the Medical Ethics Committee of Tianjin Medical University Cancer Institute & Hospital. All participants will provide written informed consent.

研究类型

介入性

注册 (估计的)

320

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Jihui Hao

研究联系人备份

学习地点

  • 中国
    • Tianjin Municipality
      • Tianjin、Tianjin Municipality、中国、300060
        • Tianjin Medical University Cancer Institute & Hospital
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Histologically or cytologically confirmed pancreatic cancer
  • Receiving first-line neoadjuvant or adjuvant chemotherapy with NALIRIFOX or AG regimen
  • ECOG performance status ≤ 2
  • Life expectancy > 3 months
  • HAMA score 7-23 (mild-to-moderate anxiety)
  • Ability to understand, communicate, and cooperate with the study; Voluntary signed informed consent

Exclusion Criteria:

  • Severe psychiatric disorders, cognitive impairment, suicidal ideation, or unstable antipsychotic medication dosage
  • Chemotherapy-related acute unstable conditions (severe myelosuppression, uncontrolled pain, active infection, or uncontrolled seizures)
  • Severe hearing impairment or intolerance to music intervention
  • Concurrent participation in other clinical trials
  • Regular mindfulness meditation or yoga practice history (≥2 times/week for ≥3 months)

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Ziwu Liuzhu Five-Element Music Therapy
Participants receive an 8-week Ziwu Liuzhu Five-Element Music Therapy program: three 20-minute sessions daily (Si period: Gong mode; Wu period: Zhi mode; You period: Yu mode). Delivered via bedside instruction during hospitalization and video supervision at home.
行为的：Ziwu Liuzhu Five-Element Music Therapy
An 8-week program delivering Gong, Zhi, and Yu musical modes at Si, Wu, and You periods respectively, 20 min per session, 3 sessions daily. Music selected from a curated library based on patient preference.
有源比较器：Mindfulness-Based Stress Reduction
Participants receive an 8-week standard Mindfulness-Based Stress Reduction program: weekly online group sessions (60 min) + twice-daily home audio-guided practice (20 min).
行为的：Mindfulness-Based Stress Reduction
An 8-week standard Mindfulness-Based Stress Reduction program consisting of weekly 60-minute online group sessions and twice-daily 20-minute home audio-guided practice sessions.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in the Hospital Anxiety and Depression Scale-Anxiety Score
大体时间：Baseline, Week 4, Week 8
Anxiety assessed using the Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A). Score ranges from 0 to 21, with higher scores indicating worse anxiety. The primary analysis is non-inferiority of Ziwu Liuzhu Five-Element Music Therapy compared to Mindfulness-Based Stress Reduction at week 8.
Baseline, Week 4, Week 8

次要结果测量

结果测量
措施说明
大体时间
Change in the Hospital Anxiety and Depression Scale-Depression Score
大体时间：Baseline, Week 4, Week 8
Depression assessed using the Hospital Anxiety and Depression Scale-Depression subscale (HADS-D). Score ranges from 0 to 21, with higher scores indicating worse depression.
Baseline, Week 4, Week 8
Change in Global Health Status/QoL Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30
大体时间：Baseline, Week 4, Week 8
Quality of life assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30. Global Health Status/QoL scale score ranges from 0 to 100, with higher scores indicating better quality of life.
Baseline, Week 4, Week 8
Change in Functional Subscales and Symptom Scores on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30
大体时间：Baseline, Week 4, Week 8
Functional subscales (physical, role, emotional, cognitive, social) and symptom scales (fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea) of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30. Each scale score ranges from 0 to 100; higher functional scores indicate better functioning, higher symptom scores indicate worse symptoms.
Baseline, Week 4, Week 8
Adherence: Practice Check-in Rate
大体时间：Daily, summarized at Week 4, Week 8
Adherence measured by the proportion of days with completed music listening sessions (check-in rate), weekly online group session attendance (for Mindfulness-Based Stress Reduction group), and practice log completion rate.
Daily, summarized at Week 4, Week 8
Incidence of Adverse Events
大体时间：Daily, summarized at Week 4, Week 8
Safety assessed by the incidence and severity of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, including but not limited to: neutropenia, leukopenia, thrombocytopenia, anemia, diarrhea, nausea, vomiting, and fatigue. Grade ≥3 events are reported within 24 hours.
Daily, summarized at Week 4, Week 8

其他结果措施

结果测量
措施说明
大体时间
Change in Neutrophil-to-Lymphocyte Ratio (NLR)
大体时间：Baseline, Week 4, Week 8
NLR is calculated as absolute neutrophil count divided by absolute lymphocyte count from peripheral blood. Higher NLR indicates greater systemic inflammation.
Baseline, Week 4, Week 8
Change in Serum Albumin
大体时间：Baseline, Week 4, Week 8
Serum albumin level measured in g/L from peripheral blood. Higher albumin indicates better nutritional status.
Baseline, Week 4, Week 8
Change in Total Protein
大体时间：Baseline, Week 4, Week 8
Serum total protein level measured in g/L from peripheral blood.
Baseline, Week 4, Week 8
Change in Hemoglobin
大体时间：Baseline, Week 4, Week 8
Hemoglobin level measured in g/L from peripheral blood. Higher hemoglobin indicates better functional status.
Baseline, Week 4, Week 8
Change in Fasting Blood Glucose
大体时间：Baseline, Week 4, Week 8
Fasting blood glucose level measured in mmol/L from peripheral blood.
Baseline, Week 4, Week 8
Change in Monocyte-to-Lymphocyte Ratio (MLR)
大体时间：Baseline, Week 4, Week 8
Change in Monocyte-to-Lymphocyte Ratio (MLR) is calculated as absolute monocyte count divided by absolute lymphocyte count from peripheral blood. Higher MLR indicates greater systemic inflammation.
Baseline, Week 4, Week 8
Change in White Blood Cell Count(WBC)
大体时间：Baseline, Week 4, Week 8
White blood cell (WBC) count measured in ×10⁹/L from peripheral blood. Abnormal WBC count indicates myelosuppression or infection.
Baseline, Week 4, Week 8

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Tianjin Medical University Cancer Institute and Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月28日

初级完成 (估计的)

2026年12月31日

研究完成 (估计的)

2027年1月31日

研究注册日期

首次提交

2026年8月27日

首先提交符合 QC 标准的

2026年8月27日

首次发布 (实际的)

2026年9月1日

研究记录更新

最后更新发布 (实际的)

2026年9月16日

上次提交的符合 QC 标准的更新

2026年9月11日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • TMUCIH-FEMT-2026-01
  • bc20262679 (其他标识符：Tianjin Cancer Hospital)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Individual participant data will not be shared due to unresolved agreements on data sharing across the four participating centers, and to ensure protection of patient privacy in accordance with institutional and ethical requirements.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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