Condition category
Cancer
Date applied
03/11/2015
Date assigned
16/11/2015
Last edited
04/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background
There are no studies that provide sufficient information on how exercise can influence the quality of patient’s life after resection (removal) of the pancreas due to pancreatic disease, such as cancer. The goal of the study is to find out if exercise can help in controlling blood glucose levels and oxidative stress after pancreatectomy (surgery to remove the pancreas).

Who can participate?
Adult patients with pancreatic cancer that are fit for surgery.

What does the study involve?
The participants are randomly allocated into one of two groups. Those in group 1 are placed in the exercise group. Those in group 2 are placed in the control group. All participants have a pancreatectomy. The participants in the exercise group exercise using a static bicycle for 12 weeks . Blood glucose, HBA1c (glycated haemoglobin, which is a form of haemoglobin that is measured to identify average plasma glucose concentrations in the blood), albumin and the uric acid levels for all participants in both groups are measured every 4 weeks for the duration of the study.

What are the possible benefits and risks of participating?
There are no risks for the participants.

Where is the study run from?
Agios Dimitrios General Hospital (under the control of Aristotle University Thessaloniki)

When is study starting and how long is it expected to run for?
May 2014 to June 2016

Who is funding the study?
Agios Dimitrios General Hospital (Greece)

Who is the main contact?
Dr Anastasios Katsourakis
tasoskatsourakis@hotmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Anastasios Katsourakis

ORCID ID

http://orcid.org/0000-0002-5151-9449

Contact details

2 Elenis Zografou str
Thessaloniki
GR- 54634
Greece
+30 2313 322 178
tasoskatsourakis@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

02/pancreas/05.2014

Study information

Scientific title

The influence of exercise on blood glucose control and the anti-oxidative ability of the blood in patients after pancreatectomy: a randomized controlled trial

Acronym

EQAP (Exercise and Quality of life After Pancreatectomy)

Study hypothesis

The aim of this study is to investigate whether pancreatectomy helps to control blood glucose after exercise, improves the anti-oxidative ability of the blood in patients and improves patient quality of life.

Ethics approval

Bioethics committee and Deontology, Medical School of Aristotle University Thessaloniki, 29/10/2015, ref: 166/ 29.10.2015

Study design

Interventional, single-centre,randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Pancreatic disease, mainly neoplastic tumors of the pancreas

Intervention

Participants are randomly allocated to one of two groups, the intervention group and the control group.
Both groups will undergo a pancreatectomy. The surgical procedure will be open and according to the location of the tumor the patient will undergo a Longmire Traverso/Whipple operation (pancreatoduodenectomy) or distal pancreatectomy with or without preservation of the spleen. Four weeks after the operation the participants in the intervention group will start to exercise, which involves 30 minutes on a static bicycle (60% of maximum heart rate) for 12 weeks. The participants in the control group do not start to exercise.

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

Measurement of blood glucose levels, HBA1c, albumin and uric acid, 12 weeks after the initiation of exercise (once every 4 weeks interval)

Secondary outcome measures

Evaluation of the quality of life (QoL) in both groups 12 weeks after the initiation of exercise

Overall trial start date

28/05/2014

Overall trial end date

30/06/2016

Reason abandoned

Eligibility

Participant inclusion criteria

Adult patients with pancreatic neoplasms that are fit for surgery

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40 patients

Participant exclusion criteria

1. Age >75 years old
2. ASA >2
3. Non resectable pancreatic tumor (according to the guidelines)
4. Pregnancy

Recruitment start date

30/05/2014

Recruitment end date

30/06/2016

Locations

Countries of recruitment

Greece

Trial participating centre

Agios Dimitrios General Hospital of Greece
2 Elenis Zografou Street
Thessaloniki
GR-54634
Greece

Sponsor information

Organisation

Agios Dimitrios General Hospital scientific committee and Aristotle University Thessaloniki

Sponsor details

2 Elenis Zografou str
Thessaloniki
GR-54634
Greece
+30 2313 322 100/178
tasoskatsourakis@hotmail.com

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Agios Dimitrios General Hospital

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

I am intending to publish the results immediately after the recruitment of statistical significant number of patients and about 2 weeks later after the statistical analysis

Intention to publish date

30/05/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

04/05/2016: Recruitment and overall study end dates changed from 30/04/2016 to 30/06/2016