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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04305067
Other study ID # B19/35
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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