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

NCT ID: NCT02921646

Last Updated: 2020-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-10

Study Completion Date

2019-07-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Metastatic Pancreatic Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

energetic expenditure measure

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

Group Type OTHER

Measure of resting energetic expenditure

Intervention Type OTHER

measure of resting energetic expenditure

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Measure of resting energetic expenditure

measure of resting energetic expenditure

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Center Eugene Marquis

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Julien Edeline, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Eugène Marquis

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre Eugène Marquis

Rennes, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2015-4-32-004

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Fatigue and Pancreas and Bile Duct Cancer Study
NCT00902759 COMPLETED EARLY_PHASE1