Clinical trial · Interventional
Baduanjin for Quality of Life in Pancreatic Cancer Chemotherapy
Effect of Baduanjin Exercise on Quality of Life and Emotional Status in Patients With Pancreatic Cancer Receiving Chemotherapy: A Multi-center Randomized Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Drug-Related Side Effects and Adverse Reactions (MeSH Term) | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Baduanjin Exercise | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Baduanjin Exercise Training
- description
- Participants receive a 12-week Baduanjin exercise program, adjusted per chemotherapy cycle (seated/standing, 10 min/day). Delivered via bedside instruction and video supervision.
- interventionNames
- Behavioral: Baduanjin Exercise
- type
- NO_INTERVENTION
- label
- Routine Care
- description
- Participants receive routine care including symptom monitoring, pain management, and psychological support, without additional exercise intervention.
Primary outcomes (1)
- measure
- Change in Global Health Status/QoL Score on the EORTC QLQ-C30
- timeFrame
- Baseline, Week 4, Week 8, Week 12
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years; Histologically or cytologically confirmed pancreatic cancer; Receiving first-line neoadjuvant or adjuvant chemotherapy with the NALIRIFOX regimen (liposomal irinotecan + 5-fluorouracil + leucovorin + oxaliplatin), including standard, reduced-dose, or modified regimens; ECOG performance status ≤ 2; Life expectancy \> 3 months; Adequate physical tolerance to perform low-intensity Baduanjin exercise, as assessed by the investigator; Ability to understand and communicate normally; Voluntary signed informed consent. Exclusion Criteria: * Severe cardiopulmonary disease or other contraindications to exercise training; Central nervous system metastases affecting exercise safety, bone metastases with high fracture risk, or severe musculoskeletal disease; Severe psychiatric or cognitive disorders that preclude cooperation with the study; Chemotherapy-related acute unstable conditions, including severe myelosuppression, uncontrolled pain, active infection, or uncontrolled seizures; Any other condition that, in the opinion of the investigator, would preclude safe participation or protocol adherence.
References
Publications (0)
Data not yet available