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

NCT07796906 | Not Yet Recruiting

• 2 other identifiers: TMUCIH-FEMT-2026-01bc20262679
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Pancreatic Cancer; Five-Element Music Therapy; Music Therapy; Psychological Distress; Mindfulness-Based Stress Reduction; Randomized Controlled Trial; Non-Inferiority Trial

Outcome Measures

Primary Outcomes (1)

• Change in the Hospital Anxiety and Depression Scale-Anxiety Score

  Anxiety assessed using the Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A). Score ranges from 0 to 21, with higher scores indicating worse anxiety. The primary analysis is non-inferiority of Ziwu Liuzhu Five-Element Music Therapy compared to Mindfulness-Based Stress Reduction at week 8.

  Baseline, Week 4, Week 8

Secondary Outcomes (5)

• Change in the Hospital Anxiety and Depression Scale-Depression Score

  Baseline, Week 4, Week 8

• Change in Global Health Status/QoL Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30

  Baseline, Week 4, Week 8

• Change in Functional Subscales and Symptom Scores on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30

  Baseline, Week 4, Week 8

• Adherence: Practice Check-in Rate

  Daily, summarized at Week 4, Week 8

• Incidence of Adverse Events

  Daily, summarized at Week 4, Week 8

Other Outcomes (7)

• Change in Neutrophil-to-Lymphocyte Ratio (NLR)

  Baseline, Week 4, Week 8

• Change in Monocyte-to-Lymphocyte Ratio (MLR)

  Baseline, Week 4, Week 8

• Change in White Blood Cell Count(WBC)

  Baseline, Week 4, Week 8

Study Arms (2)

Ziwu Liuzhu Five-Element Music Therapy

EXPERIMENTAL

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.

Behavioral: Ziwu Liuzhu Five-Element Music Therapy

Mindfulness-Based Stress Reduction

ACTIVE COMPARATOR

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).

Behavioral: Mindfulness-Based Stress Reduction

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.

Ziwu Liuzhu Five-Element Music Therapy

Mindfulness-Based Stress Reduction BEHAVIORAL

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.

Mindfulness-Based Stress Reduction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Anxiety Disorders

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Ying Wang

CONTACT

82+022-23340123; wangying3046@tjmuch.com

Jihui Hao

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistician responsible for data analysis is also masked to group allocation. Data are coded with randomization numbers and analyzed under blinded conditions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study employs a parallel-group, non-inferiority design. Participants are randomly assigned in a 1:1 ratio to either the Ziwu Liuzhu Five-Element Music Therapy group or the Mindfulness-Based Stress Reduction group. Both groups are conducted concurrently across four study centers. No crossover between groups is permitted.

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: September 1, 2026
• Study Start: August 28, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: September 16, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)