An interventional study of Ziwu Liuzhu Five-Element Music Therapy and Mindfulness-Based Stress Reduction in Pancreatic Neoplasms, Pancreatic Cancer and Anxiety, sponsored by Tianjin Medical University Cancer Institute and Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Tianjin Medical University Cancer Institute and Hospital · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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
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 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.
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.
Change in the Hospital Anxiety and Depression Scale-Anxiety Score
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.
Time frame: Baseline, Week 4, Week 8
Change in the Hospital Anxiety and Depression Scale-Depression Score
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: Baseline, Week 4, Week 8
Adherence: Practice Check-in Rate
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.
Time frame: Daily, summarized at Week 4, Week 8
Incidence of Adverse Events
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.
Time frame: Daily, summarized at Week 4, Week 8
Change in Neutrophil-to-Lymphocyte Ratio (NLR)
NLR is calculated as absolute neutrophil count divided by absolute lymphocyte count from peripheral blood. Higher NLR indicates greater systemic inflammation.
Time frame: Baseline, Week 4, Week 8
Change in Monocyte-to-Lymphocyte Ratio (MLR)
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.
Time frame: Baseline, Week 4, Week 8
Change in White Blood Cell Count(WBC)
White blood cell (WBC) count measured in ×10⁹/L from peripheral blood. Abnormal WBC count indicates myelosuppression or infection.
Time frame: Baseline, Week 4, Week 8
Change in Serum Albumin
Serum albumin level measured in g/L from peripheral blood. Higher albumin indicates better nutritional status.
Time frame: Baseline, Week 4, Week 8
Change in Total Protein
Serum total protein level measured in g/L from peripheral blood.
Time frame: Baseline, Week 4, Week 8
Change in Hemoglobin
Hemoglobin level measured in g/L from peripheral blood. Higher hemoglobin indicates better functional status.
Time frame: Baseline, Week 4, Week 8
Change in Fasting Blood Glucose
Fasting blood glucose level measured in mmol/L from peripheral blood.
Time frame: Baseline, Week 4, Week 8
Plan to share: No — 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.
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Tianjin Medical University Cancer Institute and Hospital