[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653963":3},{"organization":4,"outcomesModule":7,"designInfo":58,"detailedDescription":69,"studyPopulation":63,"armGroups":70,"interventions":81,"overallOfficials":87,"centralContacts":91,"locations":97,"responsibleParty":114,"collaborators":63,"id":116,"slug":117,"hasResults":118,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":118,"sex":124,"minAge":125,"maxAge":63,"enrollmentInfo":126,"targetDuration":63,"studyType":129,"phases":130,"briefSummary":132,"conditions":133,"keywords":137,"overallStatus":145,"whyStopped":63,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":150,"completionDateStruct":151,"leadSponsor":153,"locationsCount":154},{"fullName":5,"class":6},"Tianjin Medical University Cancer Institute and Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":36},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Global Health Status\u002FQoL 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\u002FQoL scale score ranges from 0 to 100, with higher scores indicating better quality of life.","Baseline, Week 4, Week 8, Week 12",[14,17,20,23,26,29,33],{"measure":15,"description":16,"timeFrame":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.",{"measure":18,"description":19,"timeFrame":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.",{"measure":21,"description":22,"timeFrame":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.",{"measure":24,"description":25,"timeFrame":12},"Change in Number of Completed Chemotherapy Cycles","Treatment tolerance measured by the total number of NALIRIFOX chemotherapy cycles actually completed.",{"measure":27,"description":28,"timeFrame":12},"Change in Body Weight","Body weight measured in kilograms (kg). Weight change from baseline (in kg) is also recorded.",{"measure":30,"description":31,"timeFrame":32},"Adherence: Exercise Check-in Rate","Adherence measured by daily check-in rate (proportion of days with completed exercise sessions), exercise duration (minutes\u002Fday), and exercise format (seated\u002Fstanding). Wristband data (heart rate, steps) are recorded when available.","Daily, summarized at Week 4, Week 8, Week 12",{"measure":34,"description":35,"timeFrame":32},"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.",[37,40,43,46,49,52,55],{"measure":38,"description":39,"timeFrame":12},"Change in Neutrophil-to-Lymphocyte Ratio (NLR)","NLR is calculated as absolute neutrophil count divided by absolute lymphocyte count from peripheral blood. Higher NLR indicates greater systemic inflammation.",{"measure":41,"description":42,"timeFrame":12},"Change in Monocyte-to-Lymphocyte Ratio (MLR)","MLR is calculated as absolute monocyte count divided by absolute lymphocyte count from peripheral blood. Higher MLR indicates greater systemic inflammation.",{"measure":44,"description":45,"timeFrame":12},"Change in Serum Albumin","Serum albumin level measured in g\u002FL from peripheral blood. Higher albumin indicates better nutritional status.",{"measure":47,"description":48,"timeFrame":12},"Change in Total Protein","Serum total protein level measured in g\u002FL from peripheral blood.",{"measure":50,"description":51,"timeFrame":12},"Change in Hemoglobin","Hemoglobin level measured in g\u002FL from peripheral blood. Higher hemoglobin indicates better functional status.",{"measure":53,"description":54,"timeFrame":12},"Change in Fasting Blood Glucose","Fasting blood glucose level measured in mmol\u002FL from peripheral blood.",{"measure":56,"description":57,"timeFrame":12},"Change in White Blood Cell Count","White blood cell (WBC) count measured in ×10⁹\u002FL from peripheral blood. Abnormal WBC count indicates myelosuppression or infection.",{"allocation":59,"interventionModel":60,"interventionModelDescription":61,"primaryPurpose":62,"observationalModel":63,"timePerspective":63,"maskingInfo":64},"RANDOMIZED","PARALLEL","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\u002Fstanding) 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.","TREATMENT",null,{"masking":65,"maskingDescription":66,"whoMasked":67},"SINGLE","The statistician responsible for data analysis is also masked to group allocation. Data are coded with randomization numbers and analyzed under blinded conditions.",[68],"OUTCOMES_ASSESSOR","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.\n\nPain 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.\n\nA 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.\n\nStudy 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.\n\nStudy Design This is a multicenter, prospective, parallel-group randomized controlled trial with a 1:1 allocation ratio to the intervention or control group.\n\nParticipants Inclusion criteria: age ≥18 years; histologically confirmed pancreatic cancer; first-line neoadjuvant\u002Fadjuvant 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.\n\nIntervention\n\nThe 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:\n\nDays 1-3 (acute phase): seated Baduanjin, 10 minutes\u002Fsession, 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\u002Fsession, once daily, RPE Borg 9-11; Days 13-14 (late recovery): standing Baduanjin, 10 minutes\u002Fsession, 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.\n\nThe control group receives routine care at each center (symptom monitoring, pain management, psychological support, nutritional counseling, etc.) without additional exercise intervention.\n\nOutcome 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).\n\nSecondary outcomes: Anxiety and depression (HADS-A and HADS-D), pulmonary function (FEV1, FVC), and exercise tolerance (6-minute walk test), assessed at T0-T3.\n\nExploratory outcomes: Biomarkers including NLR, MLR, albumin, total protein, hemoglobin, and glucose, assessed prior to each chemotherapy cycle.\n\nTreatment tolerance: Number of completed chemotherapy cycles and body weight change.\n\nAdherence: Daily check-in rate, exercise log completion rate, and wristband data.\n\nSafety: 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.\n\nEthics 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.",[71,77],{"label":72,"type":73,"description":74,"interventionNames":75},"Baduanjin Exercise Training","EXPERIMENTAL","Participants receive a 12-week Baduanjin exercise program, adjusted per chemotherapy cycle (seated\u002Fstanding, 10 min\u002Fday). Delivered via bedside instruction and video supervision.",[76],"Behavioral: Baduanjin Exercise",{"label":78,"type":79,"description":80,"interventionNames":63},"Routine Care","NO_INTERVENTION","Participants receive routine care including symptom monitoring, pain management, and psychological support, without additional exercise intervention.",[82],{"type":83,"name":84,"description":85,"armGroupLabels":86,"otherNames":63},"BEHAVIORAL","Baduanjin Exercise","A 12-week phased Baduanjin exercise program guided by FITT principles. Includes seated\u002Fstanding forms for 10 minutes daily, adjusted to chemotherapy cycles. Delivered via supervised sessions and daily check-ins.",[72],[88],{"name":89,"affiliation":5,"role":90},"Jihui Hao","PRINCIPAL_INVESTIGATOR",[92],{"name":93,"role":94,"phone":95,"phoneExt":63,"email":96},"Ying Wang Director of Nursing Administration Office","CONTACT","82+022-23340123","wangying3046@tjmuch.com",[98],{"facility":99,"status":63,"city":100,"state":101,"zip":102,"country":103,"countryCode":104,"cosmosGeoPoint":105,"geoPoint":110,"contacts":111},"Tianjin Medical University Cancer Institute & Hospital","Tianjin","Tianjin Municipality","300060","China","CN",{"type":106,"coordinates":107},"Point",[108,109],117.17667,39.14222,{"lat":109,"lon":108},[112],{"name":113,"role":94,"phone":95,"phoneExt":63,"email":96},"Ying Wang",{"type":115,"investigatorFullName":63,"investigatorTitle":63,"investigatorAffiliation":63,"oldNameTitle":63,"oldOrganization":63},"SPONSOR","100653963","baduanjin-for-quality-of-life-in-pancreatic-cancer-chemotherapy-100653963",false,"NCT07791550","Baduanjin for Quality of Life in Pancreatic Cancer Chemotherapy","Effect of Baduanjin Exercise on Quality of Life and Emotional Status in Patients With Pancreatic Cancer Receiving Chemotherapy: A Multi-center Randomized Clinical Trial","BDJ-PC","Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* 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.","ALL","18 Years",{"count":127,"type":128},96,"ESTIMATED","INTERVENTIONAL",[131],"NA","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.\n\nThis 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.\n\nThe 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.",[134,135,136],"Pancreatic Neoplasms","Pancreatic Cancer","Drug-Related Side Effects and Adverse Reactions (MeSH Term)",[135,138,139,140,141,142,143,144],"Baduanjin","Exercise Therapy","Chemotherapy","Randomized Controlled Trial","Quality of Life","Mental Health","Multicenter Study","NOT_YET_RECRUITING","2026-08-27",{"date":148,"type":149},"2026-08-28","ACTUAL",{"date":148,"type":128},{"date":152,"type":128},"2027-02-20",{"name":5,"class":6},1]