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Completed

NCT Number: NCT04305067

PRECISE: Pancreatic Cancer and Exercise

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

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Key information

Conditions

Pancreas Adenocarcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Belfast City Hospital

Belfast, BT5 5JU, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

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

    Time frame: At baseline

    The number of participants that agree to participate or are excluded

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

    Time frame: At conclusion of the 16 week exercise intervention

    The number of participants that withdraw from the study

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

    Time frame: At conclusion of the 16 week exercise intervention

    Determine the percentage of participants adhering to the exercise intervention

  4. Feasibility - participant experience: semi-structured interviews

    Time frame: At conclusion of the 16 week exercise intervention

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

Secondary outcomes

  1. Anthropometric assessment

    Time frame: At baseline, 16 weeks, 3 month follow-up

    Height will be measured in cm and body weight in k, which will be combined to report BMI in kg/m (squared).

  2. Hip and waist circumference analysis

    Time frame: At baseline, 16 weeks, 3 month follow-up

    Hip and waist circumference will be measured in cm.

  3. Functional muscle endurance assessment

    Time frame: At baseline, 16 weeks, 3 month follow-up

    The amount of repetitions achieved during a 30 second sit-to-stand test will be recorded.

  4. Physical fitness assessment

    Time frame: At baseline, 16 weeks, 3 month follow-up

    Distance covered in meters during a six minute walk test will be recorded.

  5. Perceived physical activity levels

    Time frame: At baseline, 16 weeks, 3 month follow-up

    Patients will complete an International Physical Activity Questionnaire (IPAQ-SF). This questionnaire will comprise 4 generic items to obtain comparable health-related physical activity. Patients will detail the number of days, hours and minutes that they undertake (1) vigorous exercise (2) moderate exercise (3) walking exercise and (4) sitting. Total physical activity will be generated and monitored for improvement or decline. Higher reported scores indicate higher levels of self-reported physical activity.

  6. Cancer-related fatigue by questionnaire

    Time frame: At baseline, 16 weeks, 3 month follow-up

    Fatigue will be measured by the Functional Assessment of Cancer Therapy - Fatigue (FACIT-Fatigue) questionnaire. Patients will score several fatigue items over the past 7 days on a scale (0 = not at all; 4 = very much), generating a total (0 - 52) with higher scores linked to greater quality of life.

  7. Patient rated pain by questionnaire

    Time frame: At baseline, 16 weeks, 3 month follow-up

    Pain will be measured using the Brief Pain Inventory (BPI). Pain is scored on a scale 0 - 10, with higher scores indicating higher pain levels.

  8. Well-being by questionnaire

    Time frame: At baseline, 16 weeks, 3 month follow-up

    Quality of life will be measured by the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire. This questionnaire is scored on a scale of 0 - 4, with 0 indicating not at all, and 4 indicating very much. Higher scores indicate poorer quality of life.

  9. Health related quality of life by questionnaire

    Time frame: At baseline, 16 weeks, 3 month follow-up

    Quality of life will be measured by the EuroQOL Five Dimension Questionnaire (EQ5D). Patients will select a level of difficulty (I have no - I have extreme) on that particular days health for mobility, self-care, usual activities, pain / discomfort and anxiety / depression. Patients will then rate 'how good' or 'how bad' their health is on that day using a 100 point scale (0 = worst health you can imagine; 100 = best health you can imagine).

  10. Health economics

    Time frame: At 16 weeks

    Health resource use will be evaluated by a Health Economics Questionnaire

Sponsors and collaborators

Lead sponsor

Queen's University, Belfast

Other

Collaborators

  • Belfast Health and Social Care Trust
  • Pancreatic Cancer UK

Registry information

Official study title

PRECISE: PancREatic Cancer and Individualised Supervised Exercise: a Feasibility Study

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 12, 2020
Registry last updated
Feb 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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