Relationship Between Evolution Of Resting Energy Expenditure And Tumoral Response To Chemotherapy In Patients Suffering From Pancreas Cancer

Study Overview

Relationship Between Evolution of Resting Energy Expenditure and Tumoral Response to Chemotherapy in Patients Suffering From Pancreas Cancer

The purpose of this study is to determine whether evolution of resting energetic expenditure is a predictive marker of tumoral response for patients suffering from metastatic pancreatic cancer and treated with 1st line of chemotherapy.

N/A

Metastatic Pancreatic Cancer

OTHER: Measure of resting energetic expenditure

2015-4-32-004

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2016-09-28	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2020-01-23
First Submitted that Met QC Criteria 2016-09-30	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2020-01-27
First Posted (ACTUAL) 2016-10-03	Results First Posted N/A	Last Verified 2020-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Other

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
OTHER: energetic expenditure measure To a standard treatment by chemotherapy, energetic expenditure will be measured 5 times during the study.	OTHER: Measure of resting energetic expenditure measure of resting energetic expenditure

Participant Group/Arm

Intervention/Treatment

OTHER: energetic expenditure measure

To a standard treatment by chemotherapy, energetic expenditure will be measured 5 times during the study.

OTHER: Measure of resting energetic expenditure

measure of resting energetic expenditure

Primary Outcome Measures	Measure Description	Time Frame
Resting energetic expenditure measurement by indirect calorimetry	Unit measure : calorie per day	4 months

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Pancreatic metastatic cancer
Patient older than 18 years
Initiation of a first line of chemotherapy by Folfirinox, or Gemcitabine or in combination with Nab-Paclitaxel.
At least one measurable target lesion
Patient signed consent for Energie-Pancreas study participation

Other concomitant cancer
Major general status alteration ( Performance status = 3 or 4 at inclusion)
Concomitant diseases explaining an altered general status or having an impact on energetic expenditure (i.e.chronic or severe infection, severe cardiac insufficiency, severe respiratory insufficiency, chronic inflammatory disease, recent surgery (< 1 month), ongoing Healing, hyperthyroidism.
Smoker
Patient deprived of his liberty, under guardianship, curator.
Pregnant patient or breastfeeding
Claustrophobic patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Julien Edeline, MD, Centre Eugène Marquis

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record