PRECISE: Pancreatic Cancer and Exercise

Pancreas Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04305067
• Other study ID #: B19/35
• Status: Completed
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: August 1, 2022

Study information

• Verified date: February 2024
• Source: Queen's University, Belfast
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: August 1, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Pancreas Adenocarcinoma

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United Kingdom	Belfast City Hospital	Belfast

Sponsors (3)

Lead Sponsor	Collaborator
Queen's University, Belfast	Belfast Health and Social Care Trust, Pancreatic Cancer UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Anthropometric assessment	Height will be measured in cm and body weight in k, which will be combined to report BMI in kg/m (squared).	At baseline, 16 weeks, 3 month follow-up
Secondary	Hip and waist circumference analysis	Hip and waist circumference will be measured in cm.	At baseline, 16 weeks, 3 month follow-up
Secondary	Functional muscle endurance assessment	The amount of repetitions achieved during a 30 second sit-to-stand test will be recorded.	At baseline, 16 weeks, 3 month follow-up
Secondary	Physical fitness assessment	Distance covered in meters during a six minute walk test will be recorded.	At baseline, 16 weeks, 3 month follow-up
Secondary	Perceived physical activity levels	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.	At baseline, 16 weeks, 3 month follow-up
Secondary	Cancer-related fatigue by questionnaire	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.	At baseline, 16 weeks, 3 month follow-up
Secondary	Patient rated pain by questionnaire	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.	At baseline, 16 weeks, 3 month follow-up
Secondary	Well-being by questionnaire	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.	At baseline, 16 weeks, 3 month follow-up
Secondary	Health related quality of life by questionnaire	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).	At baseline, 16 weeks, 3 month follow-up
Secondary	Health economics	Health resource use will be evaluated by a Health Economics Questionnaire	At 16 weeks