Baduanjin for Quality of Life in Pancreatic Cancer Chemotherapy

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT07791550
Status
Not Yet Recruiting

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Conditions

  • Drug-Related Side Effects and Adverse Reactions (MeSH Term)
  • Pancreatic Cancer
  • Pancreatic Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Baduanjin Exercise — BEHAVIORAL
    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.

Study Details

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.

Key Dates

First listed
Aug 28, 2026
Start date
Aug 28, 2026
Status verified
Aug 2026
Primary completion
Jan 31, 2027
Completion
Feb 20, 2027

Study Design

Enrollment
96 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Baduanjin Exercise Training
    Participants receive a 12-week Baduanjin exercise program, adjusted per chemotherapy cycle (seated/standing, 10 min/day). Delivered via bedside instruction and video supervision.
  • No Intervention: Routine Care
    Participants receive routine care including symptom monitoring, pain management, and psychological support, without additional exercise intervention.

Primary Outcome Measure

Change in Global Health Status/QoL Score on the EORTC QLQ-C30 [ Time Frame: Baseline, Week 4, Week 8, Week 12 ]

Central Contacts

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