Feasibility and efficacy of a multicomponent exercise medicine programme in patients with pancreatic cancer undergoing neoadjuvant therapy (the EXPAN trial): study protocol of a dual-centre, two-armed phase I randomised controlled trial.

INTRODUCTION: Exercise is emerging as a therapy in oncology for its physical and psychosocial benefits and potential effects on chemotherapy tolerability and efficacy. However, evidence from randomised controlled trials (RCTs) supporting exercise in patients with borderline resectable or locally advanced pancreatic cancer (PanCa) undergoing neoadjuvant therapy (NAT) are lacking. METHODS AND ANALYSIS: The EXPAN trial is a dual-centre, two-armed, phase I RCT. Forty patients with borderline resectable or locally advanced PanCa undergoing NAT will be randomised equally to an exercise intervention group (individualised exercise+standard NAT) or a usual care control group (standard NAT). The exercise intervention will be supervised and consist of moderate to vigorous intensity resistance and aerobic-based training undertaken two times a week for 45-60 min per session for a maximum period of 6 months. The primary outcome is feasibility. Secondary outcomes are patient-related and treatment-related endpoints, objectively measured physical function, body composition, psychological health and quality of life. Assessments will be conducted at baseline, prior to potential alteration of treatment (~4 months postbaseline), at completion of the intervention (maximum 6 months postbaseline) and 3-month and 6-month postintervention (maximum 9 and 12 months postbaseline). ETHICS AND DISSEMINATION: The EXPAN trial has been approved by Edith Cowan University (reference no.: 2020-02011-LUO), Sir Charles Gairdner Hospital (reference no.: RGS 03956) and St John of God Subiaco Hospital (reference no.: 1726). The study results will be presented at national/international conferences and submitted for publications in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ACTRN12620001081909.

Exercise as medicine in the management of pancreatic cancer: a case study.

INTRODUCTION: Given the poor prognosis for patients diagnosed with pancreatic cancer, therapies that enhance the ability to tolerate adjuvant treatments, reduce the loss of physical functioning and optimize quality of life are critically important. Exercise may represent such a therapy; however, no previous research has investigated the potential impact of exercise on outcomes in pancreatic cancer patients. PURPOSE: This study aimed to determine the safety and efficacy of a 6-month supervised exercise program in a pancreatic cancer patient undergoing adjuvant treatment. METHODS: A case study was performed on a 49-yr-old male diagnosed with stage IIb pancreatic cancer. The patient had surgery (Whipple resection) followed by adjuvant chemotherapy (gemcitabine and fluorouracil) and radiotherapy (45 Gy). The patient initiated a supervised exercise program involving twice weekly resistance and aerobic exercise sessions during adjuvant therapy. Outcomes were assessed at baseline and after 3 and 6 months of exercise. RESULTS: The exercise program was well tolerated with 73% attendance throughout the 6 months. No treatment toxicities prevented the patient from complying with adjuvant treatment plans. Considerable improvements were observed at both 3- and 6-month assessment points for all measures of physical capacity and functional ability, lean mass, physical activity levels, general health and disease-specific quality of life, cancer-related fatigue, sleep quality, and psychological distress. CONCLUSIONS: In this first reported clinical case, exercise led to improvements in a variety of patient outcomes during adjuvant therapy for pancreatic cancer. This initial evidence has important clinical implications, indicating that exercise may be an effective adjunct therapy for the management of pancreatic cancer. Future trials are needed to confirm and expand our initial findings.