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Trial Title:
A Case-control Study Comparing Glycaemic Control in Pancreatic Cancer Patients vs Healthy Matched Individuals.
NCT ID:
NCT05583890
Condition:
Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Conditions: Keywords:
Glycaemic control
Continuous glucose monitoring
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Device
Intervention name:
Continuous glucose monitors
Description:
Participants will wear continuous glucose monitors for a 7 day period.
Arm group label:
Healthy participants
Arm group label:
Pancreatic cancer patients not undergoing chemotherapy
Arm group label:
Pancreatic cancer patients undergoing chemotherapy
Intervention type:
Device
Intervention name:
Activity tracker
Description:
Participants will wear the activity tracker for a 7 day period.
Arm group label:
Healthy participants
Arm group label:
Pancreatic cancer patients not undergoing chemotherapy
Arm group label:
Pancreatic cancer patients undergoing chemotherapy
Intervention type:
Behavioral
Intervention name:
Food Diary
Description:
Participants will complete a food diary of everything they eat for 7 days.
Arm group label:
Healthy participants
Arm group label:
Pancreatic cancer patients not undergoing chemotherapy
Arm group label:
Pancreatic cancer patients undergoing chemotherapy
Intervention type:
Behavioral
Intervention name:
Questionnaires
Description:
Participants will complete FACT-Hep, DiPcare-Q and health inequality related questions.
Arm group label:
Healthy participants
Arm group label:
Pancreatic cancer patients not undergoing chemotherapy
Arm group label:
Pancreatic cancer patients undergoing chemotherapy
Summary:
The aim of this study is to continuously monitor blood glucose concentrations for a 7-day
period in pancreatic cancer patients whilst undergoing their typical daily routines and
to compare this to age matched healthy individuals. The investigators plan to carry out
the study on a small subset of patients, up to 30 with pancreatic cancer (15 not
undergoing chemotherapy and 15 undergoing chemotherapy) and 15 healthy individuals.
Detailed description:
The pancreas has two key functions related to digestion and metabolism. The first
function of the pancreas is to produce exocrine enzymes which are released into the small
intestine to help with the digestion of food. The second function is to produce endocrine
hormones, such as insulin and glucagon, which help regulate glycaemic control. Impaired
glucose metabolism and pancreatic cancer is temporally and pathogenically linked, with
pancreatic tumours altering the secretion of key glucose regulatory hormones. Improved
glucose regulation and lower glucose concentrations 3 months post-diagnosis of pancreatic
ductal adenocarcinoma, a type of pancreatic cancer, has shown to increase overall
survival.
The aim of this study is to continuously monitor blood glucose concentrations for a 7-day
period in pancreatic cancer patients whilst undergoing their typical daily routines and
to compare this to age matched healthy individuals. The comparison between healthy
individuals and pancreatic cancer patients will investigate the severity of the
difference between healthy glycaemic control and glycaemic control in those with
pancreatic cancer. The comparison between pancreatic cancer patients undergoing
chemotherapy and those not undergoing chemotherapy will help investigate the impact of
chemotherapy on glycaemic control. This will help provide evidence as to what impact
pancreatic cancer has on glycaemic control, whether continuous glucose monitors might be
useful to regulate symptoms in patients, as a baseline to tailor an exercise intervention
to regulate blood glucose concentrations and to investigate whether health inequalities
impact glycaemic control.
The investigators plan to carry out the study on a small subset of patients, 30 with
pancreatic cancer (15 undergoing chemotherapy and 15 not undergoing chemotherapy) and 15
healthy individuals.
Criteria for eligibility:
Study pop:
Pancreatic cancer patients aged between 18 and 85 with a performance status of 2 and
below. The patients must have jaundice relieved before participating and cannot have
diabetes at the point of diagnosis.
Healthy participants must be between 18-85 and age matched to the pancreatic cancer
patients. The participants must not have any serious underlying health conditions or take
any medications which may alter glycaemic control.
Sampling method:
Non-Probability Sample
Criteria:
Pancreatic cancer patients
Inclusion Criteria:
- Aged 18-85
- Sex: male/female
- Radiological/tissue cancer diagnosis
- World Health Organisation performance status of 2 or below
- Patients with jaundice must have jaundice relieved before participating
Exclusion Criteria:
- Pregnancy
- Planned surgery within the 7 days of wearing the monitor
- Emergency surgery
- Part of any other trial with similar interventions
- Any musculoskeletal, cardiovascular, or neurological disorder that could put them at
risk during the protocol.
- World Health Organisation performance status of above 2.
- Have diabetes at the point of diagnosis.
Healthy control group
Inclusion:
- Aged 18-85
- No serious underlying health conditions
- Age matched to pancreatic cancer patients
Exclusion:
- Take any medications which may alter blood glucose concentrations or
insulin/glucagon concentrations, regular paracetamol intake during the study period,
corticosteroids, thyroid hormones, or any anti-diabetes medication including insulin
and oral hypoglycaemics.
- Pregnant
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Lancaster University
Address:
City:
Lancaster
Zip:
LA1 4YW
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Christopher J Gaffney
Phone:
+44 (0) 1524 593 602
Email:
c.gaffney@lancaster.ac.uk
Contact backup:
Last name:
Elizabeth Wrench
Email:
l.wrench@lancaster.ac.uk
Facility:
Name:
East Lancashire Hospitals Trust
Address:
City:
Blackburn
Zip:
BB2 3HH
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Research and Development
Phone:
01254 732756
Phone ext:
82756
Email:
research@elht.nhs.uk
Contact backup:
Last name:
Sarah Ashton
Phone:
07977232658
Email:
sarah.ashton@elht.nhs.uk
Start date:
August 25, 2022
Completion date:
August 30, 2024
Lead sponsor:
Agency:
Lancaster University
Agency class:
Other
Collaborator:
Agency:
East Lancashire Hospitals NHS Trust
Agency class:
Other
Source:
Lancaster University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05583890
