Baduanjin for Quality of Life in Pancreatic Cancer Chemotherapy

NCT07791550 · tracked via the Priya Life Science China tracker

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Phase

Not applicable

Started

2026-08-28

Last updated

2026-08-28

Condition(s) studied

Pancreatic NeoplasmsPancreatic CancerDrug-Related Side Effects and Adverse Reactions (MeSH Term)

Investigational drug(s) / intervention(s)

Baduanjin Exercise

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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Change in Global Health Status/QoL Score on the EORTC QLQ-C30 — Baseline, Week 4, Week 8, Week 12
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.

Trial sites (1)

Facility	City	Region	Status
Tianjin Medical University Cancer Institute & Hospital	Tianjin	Tianjin Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07791550 on ClinicalTrials.gov ↗ ← All trials in China