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.
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.
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.
Parallel
Baduanjin Exercise
BehavioralA 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.
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.
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.
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.
Change in Number of Completed Chemotherapy Cycles
Treatment tolerance measured by the total number of NALIRIFOX chemotherapy cycles actually completed.
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.
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.
Change in Serum Albumin
Serum albumin level measured in g/L from peripheral blood. Higher albumin indicates better nutritional status.
Change in Total Protein
Serum total protein level measured in g/L from peripheral blood.
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