A Case-control Study Comparing Glycaemic Control in Pancreatic Cancer Patients vs Healthy Matched Individuals. (PanCanCGM)

Lancaster University

Status: Completed

Conditions: Pancreatic Cancer

Treatments: Behavioral: Food Diary; Behavioral: Questionnaires; Device: Activity tracker; Device: Continuous glucose monitors

Study type: Observational

Funder types: Other

Identifiers

NCT05583890

NHS REC no: 315235

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

29 participants in 3 patient groups

Healthy participants

Description:

Continuous glucose monitors will be fitted for 7 days, along with activity trackers and a food diary to monitor the impact of these factors on blood glucose concentrations. Participants will also complete questionnaires related to health inequalities and quality of life.

Treatment:

Device: Continuous glucose monitors

Device: Activity tracker

Behavioral: Questionnaires

Behavioral: Food Diary

Pancreatic cancer patients undergoing chemotherapy

Description:

Continuous glucose monitors will be fitted for 7 days, along with activity trackers and a food diary to monitor the impact of these factors on blood glucose concentrations whilst they are undergoing chemotherapy. Participants will also complete questionnaires related to health inequalities and quality of life.

Treatment:

Device: Continuous glucose monitors

Device: Activity tracker

Behavioral: Questionnaires

Behavioral: Food Diary

Pancreatic cancer patients not undergoing chemotherapy

Description:

Continuous glucose monitors will be fitted for 7 days, along with activity trackers and a food diary to monitor the impact of these factors on blood glucose concentrations. Participants will also complete questionnaires related to health inequalities and quality of life.

Treatment:

Device: Continuous glucose monitors

Device: Activity tracker

Behavioral: Questionnaires

Behavioral: Food Diary