Metastatic Pancreatic CancerEnergiePancreaNCT02921646
Relationship Between Evolution of Resting Energy Expenditure and Tumoral Response to Chemotherapy in Patients Suffering From Pancreas Cancer
A study testing Measure of resting energetic expenditure in people with Metastatic Pancreatic Cancer, run by Center Eugene Marquis at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Cancer
- What is being tested?
- Measure of resting energetic expenditure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jul 2017to 10 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Metastatic Pancreatic Cancer
- Being tested
- Measure of resting energetic expenditure
- Keywords
- energetic expenditure
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measure of resting energetic expenditureOther
measure of resting energetic expenditure
| Study group | Role | What they receive |
|---|---|---|
| energetic expenditure measure | Other | To a standard treatment by chemotherapy, energetic expenditure will be measured 5 times during the study. Receives: Other: Measure of resting energetic expenditure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting energetic expenditure measurement by indirect calorimetry
Unit measure : calorie per day
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2016 (estimated)
- Study start10 Jul 2017
- Primary completion10 Jul 2019
- Study completion10 Jul 2019
Why it stopped: Protocol is not adapted to cancer pancreas disease as progression is very fast and patients stopped the study before 1st study assessment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center Eugene Marquis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien Edeline, MD, Principal investigator, Centre Eugène Marquis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02921646
- Sponsor's protocol ID
- 2015-4-32-004
- Acronym
- EnergiePancrea
- Status last verified
- Jan 2020
- First submitted
- 28 Sep 2016
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02921646
- Acronym / sponsor ID
- EnergiePancrea / 2015-4-32-004
- Conditions
- Metastatic Pancreatic Cancer
- Keywords
- energetic expenditure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Protocol is not adapted to cancer pancreas disease as progression is very fast and patients stopped the study before 1st study assessment
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Center Eugene MarquisUniversity, hospital or other
- Study start
- 10 Jul 2017 (actual)
- Primary completion
- 10 Jul 2019 (actual)
- Study completion
- 10 Jul 2019 (actual)
- First posted
- 3 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| energetic expenditure measure | Other | Other: Measure of resting energetic expenditureTo a standard treatment by chemotherapy, energetic expenditure will be measured 5 times during the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measure of resting energetic expendituremeasure of resting energetic expenditure | Other | energetic expenditure measure |
Primary outcome
Resting energetic expenditure measurement by indirect calorimetry
Time frame: 4 months
Unit measure : calorie per day
Results and safety
The study was stopped early (reason given: Protocol is not adapted to cancer pancreas disease as progression is very fast and patients stopped the study before 1st study assessment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julien Edeline, MD principal investigator
Centre Eugène Marquis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measure of resting energetic expenditure in people with Metastatic Pancreatic Cancer, run by Center Eugene Marquis at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Protocol is not adapted to cancer pancreas disease as progression is very fast and patients stopped the study before 1st study assessment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting energetic expenditure measurement by indirect calorimetry (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.