An interventional study of Ziwu Liuzhu Five-Element Music Therapy and Mindfulness-Based Stress Reduction in Pancreatic Neoplasms, Pancreatic Cancer and Anxiety, sponsored by Tianjin Medical University Cancer Institute and Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Tianjin Medical University Cancer Institute and Hospital · Not applicable, Interventional, and Treatment
Among 25 studies in Pancreatic Neoplasms by Tianjin Medical University Cancer Institute and Hospital — 17 open to participants now, 17 under way, 2 of them phase 3. Pancreatic Neoplasms · Tianjin Medical University Cancer Institute and Hospital.
Among the 25 studies in Pancreatic Neoplasms by Tianjin Medical University Cancer Institute and Hospital, this one is the 2nd largest by planned enrollment of the 22 interventional ones that give a count, is one of 5 that started in 2026, is one of 2 with no phase, reaches primary completion later than 9 of the 16 other live ones, and was the 25th registered.
3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,006 are open to participants now.
Browse Pancreatic Neoplasms studies →17 of the 25 studies in Pancreatic Neoplasms by Tianjin Medical University Cancer Institute and Hospital are open now, in 1 country. Recruiting first, the newest first:
Tianjin Medical University Cancer Institute and Hospital · Sites in China
Ages 18–75
Tianjin Medical University Cancer Institute and Hospital · Sites in China
Ages 18–75
Tianjin Medical University Cancer Institute and Hospital · Sites in China
Ages 18–75
Tianjin Medical University Cancer Institute and Hospital · Sites in China
Ages 18–70
Tianjin Medical University Cancer Institute and Hospital · Sites in China
Ages 18–75
By country, each count listing its studies:
Of the 745 Pancreatic Neoplasms studies recruiting now, 478 (64%) set no upper age limit and 151 (20%) stop at 75 or younger; 40 take children under 18; 59 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
25 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 15 · Phase 3 3 · Phase 4 2
First in 2012; this study’s year is marked. 5 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 320 is above the median of 47 across 2,932 interventional studies indexed under Pancreatic Neoplasms.
Median enrollment 32 across the 22 interventional studies, 496 across the 3 observational. Of the 1 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
Tianjin Medical University Cancer Institute and Hospital is the lead sponsor of 494 studies on the registry; 293 are open to participants now.
6 of the studies in Pancreatic Neoplasms by Tianjin Medical University Cancer Institute and Hospital that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06409429Phase 3Tianjin Medical University Cancer Institute and HospitalNimotuzumab Combined With GX as Postoperative Adjuvant Therapy in Pancreatic Cancer | 2027-05-30 |
| NCT07796906Tianjin Medical University Cancer Institute and HospitalFive-Element Music Therapy for Psychological Distress in Pancreatic Cancer Chemotherapy | 2026-12-31 |
| NCT07791550Tianjin Medical University Cancer Institute and HospitalBaduanjin for Quality of Life in Pancreatic Cancer Chemotherapy | 2027-01-31 |
| NCT06951997Tianjin Medical University Cancer Institute and HospitalQL1706 Plus Chidamide, AG as First-line Treatment for Metastatic Pancreatic Cancer | 2027-05-15 |
| NCT07302841Tianjin Medical University Cancer Institute and HospitalTunlametinib + AG + Cetuximab β as First-Line Therapy for Advanced Pancreatic Cancer | 2027-06-20 |
Add all 6 to your calendar (.ics) → With an account.
Among the 25 studies in Pancreatic Neoplasms by Tianjin Medical University Cancer Institute and Hospital, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
Background Pancreatic cancer patients have a high prevalence of anxiety and depression, with rates reaching 70% for depression and 80% for anxiety after diagnosis; however, 73% of those with Psychological Distress do not receive effective intervention. Psychological Distress promotes pancreatic cancer progression through sympathetic-exosome pathways, establishing an "emotion-tumor" vicious cycle. Although the NALIRIFOX or AG regimen extends survival, the incidence of grade ≥3 adverse events reaches 73.1%, and chemotherapy toxicities interact bidirectionally with Psychological Distress. Music therapy has been recommended by NCCN and other guidelines for improving Psychological Distress in cancer patients. Ziwu Liuzhu Five-Element Music Therapy integrates five-element music with chronomedicine, delivering music at specific time periods to enhance therapeutic efficacy; however, high-level evidence is lacking for pancreatic cancer patients undergoing chemotherapy.
Study Objectives This study aims to: (1) demonstrate that Ziwu Liuzhu Five-Element Music Therapy is non-inferior to Mindfulness-Based Stress Reduction in reducing anxiety in pancreatic cancer patients during chemotherapy; (2) evaluate its effects on depression, quality of life, and biomarkers.
Study Design This is a multicenter, prospective, parallel-group, non-inferiority randomized controlled trial with a 1:1 allocation ratio to either the Ziwu Liuzhu Five-Element Music Therapy group or the MBSR group.
Participants Inclusion criteria: age ≥18 years; histologically confirmed pancreatic cancer; first-line chemotherapy with NALIRIFOX or AG (nab-paclitaxel + gemcitabine) regimen; ECOG PS ≤2; life expectancy >3 months; HAMA score 7-23 (mild-to-moderate anxiety); voluntary signed informed consent. A total of 320 participants (160 per group) are planned for enrollment.
Exclusion criteria: severe psychiatric disorders, cognitive impairment, suicidal ideation, or unstable antipsychotic medication dosage; chemotherapy-related acute unstable conditions; severe hearing impairment or intolerance to music; concurrent participation in other clinical trials; regular mindfulness or yoga practice history (≥2 times/week for ≥3 months).
Intervention
The intervention group receives an 8-week Ziwu Liuzhu Five-Element Music Therapy program:
Si Period (9:00-11:00, Spleen meridian): Gong mode (e.g., "Spring River Moonlight"), 20 minutes after breakfast, once daily, 20 minutes per session.
Wu Period (11:00-13:00, Heart meridian): Zhi mode (e.g., "Purple Bamboo Tune"), before lunchtime rest, once daily, 20 minutes per session.
You Period (17:00-19:00, Kidney meridian): Yu mode (e.g., "Three Variations of Plum Blossom"), during dinner, once daily, 20 minutes per session.
During hospitalization, bedside guidance is provided by the responsible nurse. At home, exercises are supervised via video, with daily check-in recording.
The control group receives an 8-week standard Mindfulness-Based Stress Reduction program: weekly online group sessions (60 minutes/session) + twice-daily home audio-guided practice (20 minutes/session)..
Outcome Measures Primary outcome: HADS-Anxiety score (T0, T1, T2). Secondary outcomes: HADS-Depression score, EORTC QLQ-C30 quality of life score (T0, T1, T2).
Exploratory outcomes: NLR, MLR, albumin, total protein, hemoglobin, glucose (prior to each chemotherapy cycle).
Statistical Analysis Non-inferiority testing with one-sided α = 0.025. Linear mixed-effects models are used to analyze HADS-A change scores. Non-inferiority is claimed if the upper bound of the 97.5% confidence interval for the between-group difference is less than the prespecified non-inferiority margin (1.225 points). Intention-to-treat analysis is primary; per-protocol analysis is sensitivity.
Ethics and Registration This study has been approved by the Medical Ethics Committee of Tianjin Medical University Cancer Institute \& Hospital. All participants will provide written informed consent.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
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.
Time frame: Baseline, Week 4, Week 8
Change in the Hospital Anxiety and Depression Scale-Depression Score
Depression assessed using the Hospital Anxiety and Depression Scale-Depression subscale (HADS-D). Score ranges from 0 to 21, with higher scores indicating worse depression.
Time frame: 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
Quality of life assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30. Global Health Status/QoL scale score ranges from 0 to 100, with higher scores indicating better quality of life.
Time frame: 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
Functional subscales (physical, role, emotional, cognitive, social) and symptom scales (fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea) of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30. Each scale score ranges from 0 to 100; higher functional scores indicate better functioning, higher symptom scores indicate worse symptoms.
Time frame: Baseline, Week 4, Week 8
Adherence: Practice Check-in Rate
Adherence measured by the proportion of days with completed music listening sessions (check-in rate), weekly online group session attendance (for Mindfulness-Based Stress Reduction group), and practice log completion rate.
Time frame: Daily, summarized at Week 4, Week 8
Incidence of Adverse Events
Safety assessed by the incidence and severity of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, including but not limited to: neutropenia, leukopenia, thrombocytopenia, anemia, diarrhea, nausea, vomiting, and fatigue. Grade ≥3 events are reported within 24 hours.
Time frame: Daily, summarized at Week 4, Week 8
Change in Neutrophil-to-Lymphocyte Ratio (NLR)
NLR is calculated as absolute neutrophil count divided by absolute lymphocyte count from peripheral blood. Higher NLR indicates greater systemic inflammation.
Time frame: Baseline, Week 4, Week 8
Change in Monocyte-to-Lymphocyte Ratio (MLR)
Change in Monocyte-to-Lymphocyte Ratio (MLR) is calculated as absolute monocyte count divided by absolute lymphocyte count from peripheral blood. Higher MLR indicates greater systemic inflammation.
Time frame: Baseline, Week 4, Week 8
Change in White Blood Cell Count(WBC)
White blood cell (WBC) count measured in ×10⁹/L from peripheral blood. Abnormal WBC count indicates myelosuppression or infection.
Time frame: Baseline, Week 4, Week 8
Change in Serum Albumin
Serum albumin level measured in g/L from peripheral blood. Higher albumin indicates better nutritional status.
Time frame: Baseline, Week 4, Week 8
Change in Total Protein
Serum total protein level measured in g/L from peripheral blood.
Time frame: Baseline, Week 4, Week 8
Change in Hemoglobin
Hemoglobin level measured in g/L from peripheral blood. Higher hemoglobin indicates better functional status.
Time frame: Baseline, Week 4, Week 8
Change in Fasting Blood Glucose
Fasting blood glucose level measured in mmol/L from peripheral blood.
Time frame: Baseline, Week 4, Week 8
Plan to share: No — Individual participant data will not be shared due to unresolved agreements on data sharing across the four participating centers, and to ensure protection of patient privacy in accordance with institutional and ethical requirements.
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Dec 2026, 4 months later.
Of 403 non-industry interventional studies with no phase under Pancreatic Neoplasms, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 75. This study's planned 4 months is below that.
Counting every sponsor, half of 430 studies reached it within 44 months; a quarter within 26 and three quarters within 75.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Tianjin Medical University Cancer Institute and Hospital →