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Life sciences · Interventional Study
ClinicalTrials.gov · September 16, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07796906). This is a study registration, not published results. Lead sponsor: Tianjin Medical University Cancer Institute and Hospital. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 320 participants (ESTIMATED). Conditions: Pancreatic Neoplasms, Pancreatic Cancer, Anxiety, Depression and/or Anxiety Symptoms, Psychological Distress. Interventions: BEHAVIORAL: Ziwu Liuzhu Five-Element Music Therapy; BEHAVIORAL: Mindfulness-Based Stress Reduction. Primary outcome measures: Change in the Hospital Anxiety and Depression Scale-Anxiety Score , Baseline, Week 4, Week 8. Brief 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.