Clinical trial · Interventional
Five-Element Music Therapy for Psychological Distress in Pancreatic Cancer Chemotherapy
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 17, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260917-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety | — | UNRESOLVED | — |
| Depression and/or Anxiety Symptoms | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Psychological Distress | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mindfulness-Based Stress Reduction | Behavioral | — | UNRESOLVED |
| Ziwu Liuzhu Five-Element Music Therapy | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ziwu Liuzhu Five-Element Music Therapy
- description
- 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.
- interventionNames
- Behavioral: Ziwu Liuzhu Five-Element Music Therapy
- type
- ACTIVE_COMPARATOR
- label
- Mindfulness-Based Stress Reduction
- description
- 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).
- interventionNames
- Behavioral: Mindfulness-Based Stress Reduction
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available