An interventional study of Baduanjin Exercise in Pancreatic Neoplasms, Pancreatic Cancer and Drug-Related Side Effects and Adverse Reactions (MeSH Term), 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 2026-08-28.
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 6th 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 10 of the 16 other live ones, and was the 24th 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 96 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.
Baduanjin is a traditional Chinese mind-body exercise originating from the Song Dynasty, integrating body adjustment, breathing regulation, and mental focus. With a metabolic equivalent of approximately 2.4 METs, it is classified as low-intensity aerobic exercise incorporating resistance, flexibility, and balance components. Accumulating evidence has demonstrated significant improvements in quality of life and psychological symptoms among various cancer populations including breast and lung cancer. However, no study has specifically investigated its effects in pancreatic cancer patients undergoing chemotherapy.
This is a multicenter, prospective, parallel-group randomized controlled trial. A total of 96 pancreatic cancer patients receiving NALIRIFOX chemotherapy will be enrolled and randomly assigned in a 1:1 ratio to either a 12-week Baduanjin exercise intervention group or a usual care control group. The intervention comprises a phased, symptom-guided program integrating seated and standing Baduanjin exercises, with intensity and format dynamically adjusted according to the temporal pattern of chemotherapy-related adverse events.
The primary outcome is quality of life assessed by the EORTC QLQ-C30. Secondary outcomes include anxiety and depression (HADS), cardiopulmonary function (FEV1, FVC, 6-minute walk test), treatment tolerance (number of completed chemotherapy cycles, body weight change), and biomarkers (CRP, NLR, etc). Safety events will be monitored throughout the study. This trial aims to provide evidence for a safe and feasible non-pharmacological exercise rehabilitation strategy for pancreatic cancer patients during chemotherapy.
Background Pancreatic cancer is a highly aggressive malignancy with a 5-year survival rate below 12%. More than 80% of patients present with consumptive symptoms at diagnosis, including weight loss and fatigue. The NALIRIFOX regimen has emerged as a first-line chemotherapy for advanced pancreatic cancer, extending median overall survival from 8.9 to 12.9 months. However, the incidence of grade ≥3 adverse events reaches 73.1%, including neutropenia (46.2%), nausea (73.1%), fatigue (65.4%), and diarrhea (55.1%). These toxicities persist throughout the chemotherapy course and severely impair patients' quality of life and treatment adherence.
Pain and psychological stress may promote pancreatic cancer progression through sympathetic-exosome pathways, establishing a "somatic-psychological" vicious cycle. Therefore, safe and effective non-pharmacological interventions are urgently needed to alleviate chemotherapy-related impairments. Regular exercise can enhance anti-tumor immune activity and improve physical and psychological symptoms; however, over 85% of pancreatic cancer patients present with cachexia at diagnosis, limiting their tolerance to conventional-intensity exercise regimens.
A 2025 network meta-analysis incorporating 121 studies and 11,072 cancer patients demonstrated that Baduanjin had the largest effect size for improving quality of life (SMD = 3.03). Baduanjin is characterized by gentle movements and controllable intensity, can be performed either standing or seated, and is well-suited to the physical condition of pancreatic cancer patients. Nevertheless, no study has specifically investigated Baduanjin in this population, and existing research is limited by small sample sizes, single-center designs, heterogeneous intervention protocols, and narrow outcome assessments.
Study Objectives This study aims to: (1) investigate the effects of Baduanjin on quality of life and psychological symptoms in pancreatic cancer patients during chemotherapy; (2) evaluate its impact on cardiopulmonary function, immune status, and treatment tolerance.
Study Design This is a multicenter, prospective, parallel-group randomized controlled trial with a 1:1 allocation ratio to the intervention or control group.
Participants Inclusion criteria: age ≥18 years; histologically confirmed pancreatic cancer; first-line neoadjuvant/adjuvant chemotherapy with the NALIRIFOX regimen; ECOG PS ≤2; life expectancy >3 months; and voluntary informed consent. Exclusion criteria are detailed in the study protocol. A total of 96 participants (48 per group) are planned for enrollment.
Intervention
The intervention group receives a 12-week phased Baduanjin training program guided by the FITT principle, with dynamic adjustments according to the temporal distribution of adverse events across the 14-day chemotherapy cycle:
Days 1-3 (acute phase): seated Baduanjin, 10 minutes/session, once daily, RPE Borg 6-8; Days 4-10 (early recovery): if severe myelosuppression, diarrhea, or fatigue occurs, Baduanjin is suspended and replaced by bedside deep breathing exercises and ankle pumping; Days 11-12 (mid-recovery): seated Baduanjin, 10 minutes/session, once daily, RPE Borg 9-11; Days 13-14 (late recovery): standing Baduanjin, 10 minutes/session, once daily, RPE Borg 9-11; During hospitalization, one-on-one bedside instruction is provided by the responsible nurse. At home, exercises are supervised via video, with daily check-in recording. The program adheres to the RAMP principles: low-intensity ramp-up, symptom-guided assessment, multi-stage implementation, safety-first protocol, and quantifiable progress tracking.
The control group receives routine care at each center (symptom monitoring, pain management, psychological support, nutritional counseling, etc.) without additional exercise intervention.
Outcome Measures Primary outcome: Quality of life assessed by the EORTC QLQ-C30 at baseline (T0), week 4 (T1), week 8 (T2), and week 12 (T3).
Secondary outcomes: Anxiety and depression (HADS-A and HADS-D), pulmonary function (FEV1, FVC), and exercise tolerance (6-minute walk test), assessed at T0-T3.
Exploratory outcomes: Biomarkers including NLR, MLR, albumin, total protein, hemoglobin, and glucose, assessed prior to each chemotherapy cycle.
Treatment tolerance: Number of completed chemotherapy cycles and body weight change.
Adherence: Daily check-in rate, exercise log completion rate, and wristband data.
Safety: Adverse events (CTCAE v5.0), recorded daily. Statistical Analysis Primary analyses follow the intention-to-treat principle. Continuous variables are compared using independent t-tests or Mann-Whitney U tests; categorical variables using χ² or Fisher's exact tests. Primary and secondary outcomes are analyzed using repeated-measures ANOVA to assess between-group differences, time effects, and interaction effects. Missing data are handled by multiple imputation.
Ethics and Registration This study has been approved by the Medical Ethics Committee of Tianjin Medical University Cancer Institute \& Hospital (Approval No.: bc20262678). 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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive a 12-week Baduanjin exercise program, adjusted per chemotherapy cycle (seated/standing, 10 min/day). Delivered via bedside instruction and video supervision.
Behavioral: Baduanjin Exercise
Participants receive routine care including symptom monitoring, pain management, and psychological support, without additional exercise intervention.
A 12-week phased Baduanjin exercise program guided by FITT principles. Includes seated/standing forms for 10 minutes daily, adjusted to chemotherapy cycles. Delivered via supervised sessions and daily check-ins.
Change in Global Health Status/QoL Score on the EORTC QLQ-C30
Quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). 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, Week 12
Change in Anxiety Score on the HADS-A
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.
Time frame: Baseline, Week 4, Week 8, Week 12
Change in Depression Score on the HADS-D
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, Week 12
Change in 6-Minute Walk Test Distance
Exercise tolerance assessed by the 6-minute walk test (6MWT). Distance walked in 6 minutes is recorded in meters. Pre- and post-test vital signs (heart rate, blood pressure, SpO₂) and Borg Rating of Perceived Exertion (6-20 scale) are also recorded.
Time frame: Baseline, Week 4, Week 8, Week 12
Change in Number of Completed Chemotherapy Cycles
Treatment tolerance measured by the total number of NALIRIFOX chemotherapy cycles actually completed.
Time frame: Baseline, Week 4, Week 8, Week 12
Change in Body Weight
Body weight measured in kilograms (kg). Weight change from baseline (in kg) is also recorded.
Time frame: Baseline, Week 4, Week 8, Week 12
Adherence: Exercise Check-in Rate
Adherence measured by daily check-in rate (proportion of days with completed exercise sessions), exercise duration (minutes/day), and exercise format (seated/standing). Wristband data (heart rate, steps) are recorded when available.
Time frame: Daily, summarized at Week 4, Week 8, Week 12
Incidence of Adverse Events
Safety assessed by the incidence and severity of adverse events graded according to CTCAE v5.0, including but not limited to: neutropenia, leukopenia, thrombocytopenia, anemia, diarrhea, and fatigue. Grade ≥3 events are reported within 24 hours.
Time frame: Daily, summarized at Week 4, Week 8, Week 12
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, Week 12
Change in Monocyte-to-Lymphocyte Ratio (MLR)
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, Week 12
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, Week 12
Change in Total Protein
Serum total protein level measured in g/L from peripheral blood.
Time frame: Baseline, Week 4, Week 8, Week 12
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, Week 12
Change in Fasting Blood Glucose
Fasting blood glucose level measured in mmol/L from peripheral blood.
Time frame: Baseline, Week 4, Week 8, Week 12
Change in White Blood Cell Count
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, Week 12
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 Jan 2027, 5 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 5 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 →