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.
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
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
Parallel
Ziwu Liuzhu Five-Element Music Therapy
BehavioralAn 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.
Mindfulness-Based Stress Reduction
BehavioralAn 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.
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.
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.
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.
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.
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.
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.
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.
Change in Serum Albumin
Serum albumin level measured in g/L from peripheral blood. Higher albumin indicates better nutritional status.
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