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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
96
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.
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
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
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