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

September 11, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

320

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jihui Hao

Study Contact Backup

Study Locations

  • China
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300060
        • Tianjin Medical University Cancer Institute & Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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.
Active Comparator: 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).
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Hospital Anxiety and Depression Scale-Anxiety Score
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Hospital Anxiety and Depression Scale-Depression Score
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Neutrophil-to-Lymphocyte Ratio (NLR)
Time Frame: 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
Time Frame: 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
Time Frame: Baseline, Week 4, Week 8
Serum total protein level measured in g/L from peripheral blood.
Baseline, Week 4, Week 8
Change in Hemoglobin
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 28, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

August 27, 2026

First Submitted That Met QC Criteria

August 27, 2026

First Posted (Actual)

September 1, 2026

Study Record Updates

Last Update Posted (Actual)

September 16, 2026

Last Update Submitted That Met QC Criteria

September 11, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMUCIH-FEMT-2026-01
  • bc20262679 (Other Identifier: Tianjin Cancer Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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