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

January 23, 2020 updated by: Center Eugene Marquis

Monocentric, Prospective Study Assessing the Feasibility to Use Resting Energy Expenditure by Indirect Calorimetry as Prognostic Marker of Tumoral Response to 1st Line Chemotherapy in Patients Suffering From Metastatic Pancreatic 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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • France
      • Rennes, France, 35042
        • Centre Eugène Marquis

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Center Eugene Marquis

Investigators

  • Principal Investigator: Julien Edeline, MD, Centre Eugène Marquis

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 Major Dates

Study Start (Actual)

July 10, 2017

Primary Completion (Actual)

July 10, 2019

Study Completion (Actual)

July 10, 2019

Study Registration Dates

First Submitted

September 28, 2016

First Submitted That Met QC Criteria

September 30, 2016

First Posted (Estimate)

October 3, 2016

Study Record Updates

Last Update Posted (Actual)

January 27, 2020

Last Update Submitted That Met QC Criteria

January 23, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-4-32-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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