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

Not Applicable

Terminated

• Conditions: Metastatic Pancreatic Cancer
• Interventions: Other: Measure of resting energetic expenditure

• Registration Number: NCT02921646
• Lead Sponsor: Center Eugene Marquis

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-09-28
• Study First Submitted QC: 2016-09-30
• Study First Posted: 2016-10-03
• Study Start: 2017-07-10
• Primary Completion: 2019-07-10
• Study Completion: 2019-07-10
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-23
• Last Update Posted: 2020-01-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
energetic expenditure measure	Measure of resting energetic expenditure	To a standard treatment by chemotherapy, energetic expenditure will be measured 5 times during the study.

Primary Outcome Measures

Name	Time	Method
Resting energetic expenditure measurement by indirect calorimetry	4 months	Unit measure : calorie per day

Trial Locations

Locations (1)

Centre Eugène Marquis; 🇫🇷 Rennes, France