NCT02921646

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 3, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

July 10, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2019

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

2 years

First QC Date

September 28, 2016

Last Update Submit

January 23, 2020

Conditions

Metastatic Pancreatic Cancer

Keywords

energetic expenditure

Outcome Measures

Primary Outcomes (1)

  • Resting energetic expenditure measurement by indirect calorimetry

    Unit measure : calorie per day

    4 months

Study Arms (1)

energetic expenditure measure

OTHER

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

Other: Measure of resting energetic expenditure

Interventions

Measure of resting energetic expenditureOTHER

measure of resting energetic expenditure

energetic expenditure measure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Other concomitant cancer
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Eugène Marquis

Rennes, 35042, France

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Julien Edeline, MD

    Centre Eugène Marquis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2016

First Posted

October 3, 2016

Study Start

July 10, 2017

Primary Completion

July 10, 2019

Study Completion

July 10, 2019

Last Updated

January 27, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)