Pancreas Adenocarcinoma Clinical Trial
Official title:
PRECISE: PancREatic Cancer and Individualised Supervised Exercise: a Feasibility Study
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 |
Verified date | February 2024 |
Source | Queen's University, Belfast |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Belfast City Hospital | Belfast |
Lead Sponsor | Collaborator |
---|---|
Queen's University, Belfast | Belfast Health and Social Care Trust, Pancreatic Cancer UK |
United Kingdom,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06065891 -
Para-aortic Lymph Node Metastasis in Resectable Pancreatic Cancer
|
N/A | |
Recruiting |
NCT05351983 -
Patient-derived Organoids Drug Screen in Pancreatic Cancer
|
N/A | |
Completed |
NCT01774162 -
EUS-guided Fine Needle Biopsy With a New Core Histology Needle Versus Conventional Fine Needle Aspiration
|
N/A | |
Recruiting |
NCT04164602 -
The Occurence of Pancreatic Cancer Studied in Association With Newly Diagnosed Diabetes in the Elderly
|
||
Recruiting |
NCT05325281 -
CPI-613 (Devimistat) in Combination With Chemoradiation in Patients With Pancreatic Adenocarcinoma
|
Phase 1 | |
Completed |
NCT05161013 -
A Proof-of-Concept Study Evaluating LINFU™
|
N/A | |
Recruiting |
NCT05470920 -
Genetic Testing Decision Aid
|
N/A | |
Recruiting |
NCT04099134 -
PACAREG: a Multicenter Registry Trial in Pancreatic Ductal Adencarcinoma
|
||
Completed |
NCT05518071 -
FLUOPANC-trial - Fluorescence-guided Surgery of Pancreatic and Bileduct Tumors Using cRGD-ZW800-1
|
Phase 2 | |
Withdrawn |
NCT04045730 -
The Study of Gemcitabine Plus Nab-Paclitaxel in Combination With Pegvorhyaluronidase Alfa (PVHA; PEGPH20) and Pembrolizumab as Front-line Treatment for Metastatic Pancreatic Adenocarcinoma.
|
Phase 2 | |
Recruiting |
NCT06160596 -
Analyzing and Solving Exceptional Long-term Survivors in Solid Tumors With Poor Prognosis
|
||
Recruiting |
NCT04636788 -
Circulating Extracellular Exosomal Small RNA as Potential Biomarker for Human Pancreatic Cancer
|
N/A | |
Recruiting |
NCT04435067 -
Evaluation of Clinical, Radiomics and Molecular Features of Lung Metastasis in PDAC Patients (LUMACA Trial)
|
||
Recruiting |
NCT04571294 -
Para-aortic Lymphnodes Removal During Upfront Pancreaticoduodenectomy
|
N/A | |
Recruiting |
NCT06451497 -
Phase 1 Trial of ZM008 as Single Agent and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
|
Phase 1 | |
Active, not recruiting |
NCT03472716 -
The βIG-H3 Protein: a New Marker in PANCreatic Adenocarcinoma (BIGHPANC)
|
||
Completed |
NCT03532347 -
Endoscopic Ultrasound Guided Tissue Sampling (The SharkBITE Study)
|
N/A | |
Withdrawn |
NCT06090318 -
Milademetan in Combination With Atezolizumab in Patients With Advanced Solid Tumors With CDKN2A Loss
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT06381882 -
The Role of the Human Microbiome in Patients After Pancreatic Resection.
|
||
Recruiting |
NCT03544255 -
Drug Screening of Pancreatic Cancer Organoids Developed From EUS-FNA Guided Biopsy Tissues
|