Back to resultsRelationship Between Evolution of Resting Energy Expenditure and Tumoral Response to Chemotherapy in Patients Suffering From Pancreas Cancer (EnergiePancrea)
Primary Purpose
Metastatic Pancreatic Cancer
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Measure of resting energetic expenditure
Sponsored by
About this trial
This is an interventional other trial for Metastatic Pancreatic Cancer focused on measuring energetic expenditure
Eligibility Criteria
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
Sites / Locations
- Centre Eugène Marquis
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
energetic expenditure measure
Arm Description
To a standard treatment by chemotherapy, energetic expenditure will be measured 5 times during the study.
Outcomes
Primary Outcome Measures
Resting energetic expenditure measurement by indirect calorimetry
Unit measure : calorie per day
Secondary Outcome Measures
Full Information
NCT ID
NCT02921646
First Posted
September 28, 2016
Last Updated
January 23, 2020
Sponsor
Center Eugene Marquis
1. Study Identification
Unique Protocol Identification Number
NCT02921646
Brief Title
Relationship Between Evolution of Resting Energy Expenditure and Tumoral Response to Chemotherapy in Patients Suffering From Pancreas Cancer
Acronym
EnergiePancrea
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Terminated
Why Stopped
Protocol is not adapted to cancer pancreas disease as progression is very fast and patients stopped the study before 1st study assessment
Study Start Date
July 10, 2017 (Actual)
Primary Completion Date
July 10, 2019 (Actual)
Study Completion Date
July 10, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Center Eugene Marquis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Pancreatic Cancer
Keywords
energetic expenditure
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
energetic expenditure measure
Arm Type
Other
Arm Description
To a standard treatment by chemotherapy, energetic expenditure will be measured 5 times during the study.
Intervention Type
Other
Intervention Name(s)
Measure of resting energetic expenditure
Intervention Description
measure of resting energetic expenditure
Primary Outcome Measure Information:
Title
Resting energetic expenditure measurement by indirect calorimetry
Description
Unit measure : calorie per day
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julien Edeline, MD
Organizational Affiliation
Centre Eugène Marquis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Eugène Marquis
City
Rennes
ZIP/Postal Code
35042
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Relationship Between Evolution of Resting Energy Expenditure and Tumoral Response to Chemotherapy in Patients Suffering From Pancreas Cancer
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