Abstract
Background: Patients with resectable pancreatic ductal adenocarcinoma (PDAC), undergoing adjuvant chemotherapy can experience an array of complications including fatigue, pain and the loss of physical function. Accumulating evidence from largely early stage breast cancer studies supports exercise as an adjunct therapy to help mitigate treatment complications. However, there is a lack of evidence of its feasibility in pancreatic cancer. The purpose of this study is to explore the initial feasibility of delivering a supervised, individualized, and progressive concurrent exercise intervention to individuals with resectable PDAC who are undergoing adjuvant therapy. Methodology: Ten patients with resectable PDAC undergoing adjuvant chemotherapy will be recruited. Clinical care teams will screen patients against inclusion criteria to determine eligibility. All enrolled participants will complete a 16-week, supervised, tailored, moderate intensity exercise intervention consisting of aerobic and muscle strengthening activities. The primary outcome will be feasibility of delivering a supervised exercise intervention. Secondary outcomes will include measures of physical fitness, fatigue, and quality of life. Outcomes will be measured at baseline (T1), 16 weeks (T2) and 3 months post intervention (T3). The feasibility, acceptability and potential utility of the supervised exercise intervention will be explored qualitatively through semi-structured interviews with key stakeholders (e.g. active participants, eligible participants that declined participation and the research staff including exercise physiologists and recruiting clinicians). The use of health and social care services, medications and personal expenses incurred during the trial will also be used to determine cost-effectiveness of this intervention and a potential further RCT in PDAC. Discussion: The overall aim of this study is to determine the utility of a supervised, tailored, moderate intensity exercise intervention in PDAC patients undergoing adjuvant chemotherapy. This feasibility study will help inform the design of future randomised controlled trials to determine the efficacy of the exercise intervention in PDAC.
Highlights
Paragraph 4, 2nd sentence - I believe "there" should be "their" in this sentence.Eligibility criteriaThe authors should more precisely define "have tolerated at least 2 cycles" - will plans for dose reduction or switching regiments exclude patients?How recent must CT scan confirming no persistent or recurrent disease have been performed? For example, can a patient be enrolled if CT scan was 1 month ago? 2 weeks?Exercise InterventionIt would be helpful to see a list of resistance training exercises that participants will perform
This study aims to explore the initial feasibility of delivering a supervised, individualized, and progressive concurrent exercise intervention to individuals with resectable pancreatic ductal adenocarcinoma (PDAC) who are undergoing adjuvant therapy, and provide data required to design a future RCT
For the 20% of patients diagnosed with resectable PDAC, both treatment and disease complications can impact physical function and impair quality of life
Summary
Paragraph 4, 2nd sentence - I believe "there" should be "their" in this sentence.Eligibility criteriaThe authors should more precisely define "have tolerated at least 2 cycles" - will plans for dose reduction or switching regiments exclude patients?How recent must CT scan confirming no persistent or recurrent disease have been performed? For example, can a patient be enrolled if CT scan was 1 month ago? 2 weeks?Exercise InterventionIt would be helpful to see a list of resistance training exercises that participants will perform. We have approval for a study amendment to include home-based, remote supervised exercise. This has been added to the manuscript within the methodology, and our introduction has been edited to better reflect the utility of home-based exercise in the current climate. Patients with resectable pancreatic ductal adenocarcinoma (PDAC), undergoing adjuvant chemotherapy can experience an array of complications including fatigue, pain and the loss of physical function. The purpose of this study is to explore the initial feasibility of delivering a supervised, individualized, and progressive concurrent exercise intervention to individuals with resectable PDAC who are undergoing adjuvant therapy. All enrolled participants will complete a 16-week, supervised, tailored, moderate intensity exercise intervention consisting of aerobic and muscle strengthening activities. The primary outcome will be feasibility of delivering a supervised exercise intervention. Secondary outcomes will include measures of physical fitness, fatigue, and version 2
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