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Five-Element Music Therapy for Psychological Distress in Pancreatic Cancer Chemotherapy
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
320
Start Date
2026-08-28
Completion Date
2027-01-31
Last Updated
2026-09-16
Healthy Volunteers
No
Conditions
Interventions
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.
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.
Locations (1)
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China