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

Metastatic Pancreatic Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02921646
• Other study ID #: 2015-4-32-004
• Status: Terminated
• Phase: N/A
• Start date: July 10, 2017
• Est. completion date: July 10, 2019

Study information

• Verified date: January 2020
• Source: Center Eugene Marquis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: July 10, 2019
• Est. primary completion date: July 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Other:
• Measure of resting energetic expenditure
measure of resting energetic expenditure

Locations

Country	Name	City	State
France	Centre Eugène Marquis	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Center Eugene Marquis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resting energetic expenditure measurement by indirect calorimetry	Unit measure : calorie per day	4 months