PRECISE: Pancreatic Cancer and Exercise

NCT04305067 | Completed

• 1 other identifier: B19/35
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Conditions

Pancreas Adenocarcinoma

Outcome Measures

Primary Outcomes (4)

• Feasibility - recruitment: number of participants that agree to participate or are excluded

  The number of participants that agree to participate or are excluded

  At baseline

• Feasibility - attrition: number of participants that withdraw from the study

  The number of participants that withdraw from the study

  At conclusion of the 16 week exercise intervention

• Feasibility - adherence to the exercise intervention: percentage of participants adhering to the exercise intervention

  Determine the percentage of participants adhering to the exercise intervention

  At conclusion of the 16 week exercise intervention

• Feasibility - participant experience: semi-structured interviews

  Determined by qualitative evaluation, using semi-structured interviews to assess experiences, accessibility and acceptability of the exercise intervention

  At conclusion of the 16 week exercise intervention

Secondary Outcomes (10)

• Anthropometric assessment

  At baseline, 16 weeks, 3 month follow-up

• Hip and waist circumference analysis

  At baseline, 16 weeks, 3 month follow-up

• Functional muscle endurance assessment

  At baseline, 16 weeks, 3 month follow-up

• Physical fitness assessment

  At baseline, 16 weeks, 3 month follow-up

• Perceived physical activity levels

  At baseline, 16 weeks, 3 month follow-up

Study Arms (1)

Supervised aerobic and resistance exercise

EXPERIMENTAL

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

Other: Exercise

Interventions

Exercise 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.

Supervised aerobic and resistance exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Queen's University, Belfast: lead
• Pancreatic Cancer UK: collaborator
• Belfast Health and Social Care Trust: collaborator

Study Sites (1)

Belfast City Hospital

Belfast, BT5 5JU, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 37735664 DERIVED

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Richard Turkington, MD

  Queens University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior lecturer in chronic illness

Study Record Dates

• First Submitted: February 28, 2020
• First Posted: March 12, 2020
• Study Start: August 1, 2020
• Primary Completion: July 31, 2022
• Study Completion: August 1, 2022
• Last Updated: February 16, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)