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Sponsor: Tianjin Medical University Cancer Institute and Hospital
Conditions: Pancreatic Neoplasms, Pancreatic Cancer, Anxiety, Depression and/or Anxiety Symptoms, Psychological Distress
Interventions: Ziwu Liuzhu Five-Element Music Therapy, Mindfulness-Based Stress Reduction
Countries: China
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.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * Age ≥ 18 years; 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).
- Tianjin, Tianjin Municipality, China