Baduanjin for Quality of Life in Pancreatic Cancer Chemotherapy
NCT07791550 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96
Last updated 2026-08-28
Summary
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
- Pancreatic Neoplasms
- Pancreatic Cancer
- Drug-Related Side Effects and Adverse Reactions (MeSH Term)
Interventions
- BEHAVIORAL
-
Baduanjin Exercise
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.
Sponsors & Collaborators
-
Tianjin Medical University Cancer Institute and Hospital
lead OTHER
Principal Investigators
-
Jihui Hao · Tianjin Medical University Cancer Institute and Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-08-28
- Primary Completion
- 2027-01-31
- Completion
- 2027-02-20
Countries
- China
Study Locations
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