Clinical trial NCT04305067: PRECISE: Pancreatic Cancer and Exercise
Official title: PRECISE: PancREatic Cancer and Individualised Supervised Exercise: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreas Adenocarcinoma
Lead sponsor: Queen's University, Belfast
Sponsor class: OTHER
Collaborators: name: Pancreatic Cancer UK
name: Belfast Health and Social Care Trust
First posted: 2020-03-12
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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)

Primary outcomes:
measure: Feasibility - recruitment: number of participants that agree to participate or are excluded
timeFrame: At baseline
measure: Feasibility - attrition: number of participants that withdraw from the study
timeFrame: At conclusion of the 16 week exercise intervention
measure: Feasibility - adherence to the exercise intervention: percentage of participants adhering to the exercise intervention
timeFrame: At conclusion of the 16 week exercise intervention
measure: Feasibility - participant experience: semi-structured interviews
timeFrame: At conclusion of the 16 week exercise intervention
Secondary outcomes:
measure: Anthropometric assessment
timeFrame: At baseline, 16 weeks, 3 month follow-up
measure: Hip and waist circumference analysis
timeFrame: At baseline, 16 weeks, 3 month follow-up
measure: Functional muscle endurance assessment
timeFrame: At baseline, 16 weeks, 3 month follow-up
measure: Physical fitness assessment
timeFrame: At baseline, 16 weeks, 3 month follow-up
measure: Perceived physical activity levels
timeFrame: At baseline, 16 weeks, 3 month follow-up
measure: Cancer-related fatigue by questionnaire
timeFrame: At baseline, 16 weeks, 3 month follow-up
measure: Patient rated pain by questionnaire
timeFrame: At baseline, 16 weeks, 3 month follow-up
measure: Well-being by questionnaire
timeFrame: At baseline, 16 weeks, 3 month follow-up
measure: Health related quality of life by questionnaire
timeFrame: At baseline, 16 weeks, 3 month follow-up
measure: Health economics
timeFrame: At 16 weeks
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Belfast City Hospital
Study officials:
affiliation: Queens University
name: Richard Turkington, MD
role: PRINCIPAL_INVESTIGATOR
References: