PRECISE: Pancreatic Cancer and Exercise

NCT ID: NCT04305067

Last Updated: 2024-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2022-08-01

Brief Summary

The purpose of this study is to establish the feasibility of delivering a prescribed, individualised supervised aerobic and resistance exercise programme during adjuvant therapy, to improve survival and reduce symptom burden in pancreatic cancer

Detailed Description

Pancreatic ductal adenocarcinoma (PDAC) is the most common malignancy of the pancreas, representing 90% of all pancreatic neoplasms. The late presentation of symptoms and a lack of effective screening methods, means a large proportion (80-90%) are diagnosed with unresectable advanced disease, contributing to an unfavorable prognosis and dismal 5-year survival rate of ~5%. Intensive cancer treatments (i.e. surgery and chemotherapy) have debilitating complications including fatigue, pain and impaired physical function. Therefore, the maintenance of physical function and quality of life are seen as primary treatment goals for pancreatic patients, particularly during adjuvant therapy. Exercise training is emerging as an accepted component of patient care and evidence suggests regular exercise may induce an array of physiological and psychosocial benefits. However, there is a lack of evidence on the feasibility of delivering supervised exercise interventions to individuals with resectable PDAC undergoing adjuvant therapy. This study aims 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, and provide data required to design a future randomized controlled trials.

Conditions

Pancreas Adenocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Supervised aerobic and resistance exercise

16 weeks of supervised, moderate intensity, aerobic and resistance exercise. Aerobic exercise will be completed supervised, 2 days per week, commencing with a single 10 minute bout and progressing to 30 minutes of continuous aerobic exercise. Resistance exercises will involve whole body activities and commence with 1 set of each exercise (6-12 repetitions) and progress to 3 sets. The resistance exercises will gradually progress in difficulty throughout the program and will utilise daily undulating periodisation

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

Exercise programs will be individually tailored to the capabilities of each participant and gradually progressed accordingly. Each patient will be asked to complete one home-based aerobic exercise sessions each week. At baseline, 16 weeks and 3 month followup patients will complete a physical fitness assessment (30 second sit to stand and six minute walking tests) and a range of quality of life questionnaires. Upon completion of the 16 week exercise intervention, patients will be invited to partake in semi-structured interviews to determine the effectiveness of the program and their experience throughout.

Interventions

Exercise

Exercise programs will be individually tailored to the capabilities of each participant and gradually progressed accordingly. Each patient will be asked to complete one home-based aerobic exercise sessions each week. At baseline, 16 weeks and 3 month followup patients will complete a physical fitness assessment (30 second sit to stand and six minute walking tests) and a range of quality of life questionnaires. Upon completion of the 16 week exercise intervention, patients will be invited to partake in semi-structured interviews to determine the effectiveness of the program and their experience throughout.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• age ≥ 18 years
• histologically proven pancreatic ductal adenocarcinoma
• complete macroscopic resection (R0 or R1 resection)
• patients recovering from surgery in time for chemotherapy to be delivered with adjuvant intent
• prior malignancy active within the previous 3 years other than locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• deemed medically fit by treating team to participate in exercise programme
• able to provide informed consent.

Exclusion Criteria

• Macroscopically remaining tumour (R2 resection or tumour node metastasis (TNM) stage IV disease)
• Pre-existing cardiac conditions; Congestive heart failure or recent serious cardiovascular event
• Chest pain while undertaking physical activity
• Any related co-morbidities (diabetes; unstable angina; degenerative neuromuscular disease; mental health disorders; substance abuse)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pancreatic Cancer UK

OTHER

Sponsor Role: collaborator

Belfast Health and Social Care Trust

OTHER

Sponsor Role: collaborator

Queen's University, Belfast

OTHER

Sponsor Role: lead

Responsible Party

Gillian Prue

Senior lecturer in chronic illness

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard Turkington, MD

Role: PRINCIPAL_INVESTIGATOR

Queens University

Locations

Belfast City Hospital

Belfast, , United Kingdom

Countries

United Kingdom

References

Brown M, O'Connor D, Turkington R, Eatock M, Vince R, Hulme C, Bowdery R, Robinson R, Wadsley J, Maraveyas A, Prue G. Feasibility of delivering supervised exercise training following surgical resection and during adjuvant chemotherapy for pancreatic ductal adenocarcinoma (PRECISE): a case series. BMC Sports Sci Med Rehabil. 2023 Sep 21;15(1):116. doi: 10.1186/s13102-023-00722-3.

Reference Type: DERIVED

PMID: 37735664 (View on PubMed)

Other Identifiers

B19/35

Identifier Type: -

Identifier Source: org_study_id