Baduanjin for Quality of Life in Pancreatic Cancer Chemotherapy

NCT07791550 | Not Yet Recruiting

• 2 other identifiers: TMUCIH-BDJ-2026-01bc20262678
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Pancreatic Cancer; Baduanjin; Exercise Therapy; Chemotherapy; Randomized Controlled Trial; Quality of Life; Mental Health; Multicenter Study

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Week 4, Week 8, Week 12

Secondary Outcomes (7)

• Change in Anxiety Score on the HADS-A

  Baseline, Week 4, Week 8, Week 12

• Change in Depression Score on the HADS-D

  Baseline, Week 4, Week 8, Week 12

• Change in 6-Minute Walk Test Distance

  Baseline, Week 4, Week 8, Week 12

• Change in Number of Completed Chemotherapy Cycles

  Baseline, Week 4, Week 8, Week 12

• Change in Body Weight

  Baseline, Week 4, Week 8, Week 12

Other Outcomes (7)

• Change in Neutrophil-to-Lymphocyte Ratio (NLR)

  Baseline, Week 4, Week 8, Week 12

• Change in Monocyte-to-Lymphocyte Ratio (MLR)

  Baseline, Week 4, Week 8, Week 12

• Change in Serum Albumin

  Baseline, Week 4, Week 8, Week 12

Study Arms (2)

Baduanjin Exercise Training

EXPERIMENTAL

Participants receive a 12-week Baduanjin exercise program, adjusted per chemotherapy cycle (seated/standing, 10 min/day). Delivered via bedside instruction and video supervision.

Behavioral: Baduanjin Exercise

Routine Care

NO INTERVENTION

Participants receive routine care including symptom monitoring, pain management, and psychological support, without additional exercise intervention.

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.

Baduanjin Exercise Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Psychological Well-Being

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Personal Satisfaction; Behavior

Study Officials

• Jihui Hao

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Wang Director of Nursing Administration Office

CONTACT

82+022-23340123; wangying3046@tjmuch.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistician responsible for data analysis is also masked to group allocation. Data are coded with randomization numbers and analyzed under blinded conditions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study employs a parallel-group design with participants randomly assigned in a 1:1 ratio to either the intervention group or the control group. The intervention group receives a 12-week phased Baduanjin exercise training program, with intensity and format (seated/standing) dynamically adjusted according to the temporal distribution of chemotherapy-related adverse events. The control group receives routine care at each center (symptom monitoring, pain management, psychological support, nutritional counseling, etc.) without additional exercise intervention. Both groups are conducted concurrently across 4 study centers. No crossover between groups is permitted.

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 28, 2026
• Study Start: August 28, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): February 20, 2027
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)