Abstract
BACKGROUND: Pancreatic cancer is characterized by a 5-year survival rate of less than 12%, primarily because of challenges in early diagnosis, which has resulted in a generally poor prognosis for patients. With ongoing advancements in diagnostic and surgical technologies, there is an increasing focus on enhancing the postoperative quality of life for individuals with pancreatic cancer. Although existing research suggests that exercise interventions are safe for this patient population, definitive evidence regarding their efficacy remains insufficient. Consequently, this study aims to conduct a randomized controlled trial to assess the safety and efficacy of exercise interventions in enhancing muscle mass, physical function, and quality of life among patients who have undergone surgery for pancreatic cancer. METHODS: A total of 168 eligible postoperative pancreatic cancer patients will be enrolled and randomly allocated in a 1:2 ratio to either the intervention group or the control group. Participants in the intervention group will receive a personalized exercise prescription for a duration of 16 weeks, whereas participants in the control group will not receive any specific exercise prescription or intervention. The primary outcomes of this study include Changes in muscle mass, specifically the skeletal muscle index and density, from baseline to week 16, as well as assessments of physical function using the 6-Minute Walk Test (6MWT) and evaluations of quality of life through standardized scale scores. Secondary outcomes comprise assessments using the Functional Assessment of Cancer Therapy Fatigue Scale (FACT-F), the Hospital Anxiety and Depression Scale (HADS), and the Pittsburgh Sleep Quality Index (PSQI). Measurements of outcome indicators other than muscle mass will be conducted at weeks 0, 4, and 12, respectively. DISCUSSION: The impact of the personalized exercise prescription intervention will be evaluated through alterations in primary and secondary outcome indicators at both the 4-week intervention mark and the 12-week follow-up period. This trial aims to offer novel clinical insights into the efficacy of personalized exercise prescriptions in enhancing muscle mass, physical function, and quality of life among postoperative pancreatic cancer patients. TRIAL REGISTRATION: Clinical Trial Registry-China ChiCTR2500098709. Registered on 12 March 2025.