Five-Element Music Therapy for Psychological Distress in Pancreatic Cancer Chemotherapy

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT07796906
Status
Not Yet Recruiting

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Conditions

  • Anxiety
  • Depression and/or Anxiety Symptoms
  • Pancreatic Cancer
  • Pancreatic Neoplasms
  • Psychological Distress

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ziwu Liuzhu Five-Element Music Therapy — BEHAVIORAL
    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 — BEHAVIORAL
    An 8-week standard MBSR program consisting of weekly 60-minute online group sessions and twice-daily 20-minute home audio-guided practice sessions.

Study Details

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.

Key Dates

First listed
Sep 1, 2026
Start date
Aug 28, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
320 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ziwu Liuzhu Five-Element Music Therapy
    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.
  • Active Comparator: Mindfulness-Based Stress Reduction
    Participants receive an 8-week standard MBSR program: weekly online group sessions (60 min) + twice-daily home audio-guided practice (20 min).

Primary Outcome Measure

Change in HADS-Anxiety Score [ Time Frame: Baseline, Week 4, Week 8 ]

Central Contacts

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