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CompletedNCT04879316ELYUpdated May 12, 2021

Energy for Lymphocytes

An observational study in Non-small Cell Lung Cancer and Progression, Disease, sponsored by Hôpital Cochin. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-12.

Sponsored by Hôpital Cochin · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
144
Ages
18 Years and older
Sex
All
01

Study summary

CERTIM is a cohort created in July 2015 to set up a multidisciplinary follow-up of cancer patients treated with immune checkpoint inhibitors.

From the CERTIM cohort, we conducted a longitudinal, prospective, observational study (ELY) in two tertiary university centers (Cochin hospital and European Georges Pompidou Hospital), which included patients between August 2016 and October 2019 and ended follow-up in April 2020.

Patients were treated with nivolumab, at a dose of 3 mg/kg every 2 weeks, or pembrolizumab, at a dose of 2mg/kg every 3 weeks. The investigators report findings from an evaluation of rest energy expenditure (REE) assessed using indirect calorimetry in the outpatient setting before treatment with checkpoints inhibitors.

02

Conditions studied

  • Non-small Cell Lung Cancer
  • Progression, Disease

Keywords

  • cachexia
  • immunotherapy
  • carcinoma
  • Non-small cell lung cancer
  • Basal metabolism
  • Energy expenditure
  • inflammation
  • 6-month Progression free survival
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients with NSCLC initiating nivolumab or pembrolizumab in real-life conditions

Inclusion criteria

  • 18 years or older
  • Stage IV histologically proven Non Small Cell Lung Cancer (NSCLC)
  • Monotherapy with nivolumab or pembrolizumab.
  • Patients were required to have measurable disease per the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.

Exclusion criteria

Exclusion Criteria:

  • Active malignancy other than NSCLC,
  • ALK or EGFR mutated NSCLC
  • Anticancer therapy or surgery within the past 2 weeks or inability to breathe under the calorimetry.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
144 participants (actual)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • adult patients with NSCLC initiating nivolumab or pembrolizumab

    Patients underwent a multidisciplinary evaluation including consultation with an oncologist and a dietitian. Such an assessment includes subjective and objective parameters such as medical history, weight loss, current dietary intake (including energy and protein balance), physical examination and anthropometric measurements, functional and mental assessment, medications, Resting Energy Expenditure measurement using indirect calorimetry and laboratory values.

    Other: Resting Energy Expenditure measurement

Interventions

  • OtherResting Energy Expenditure measurement

    Resting Energy Expenditure measurement using indirect calorimetry

05

What researchers measure

Primary outcomes

  1. 6-month Progression-free survival

    Calculated as the percentage of participants alive and without disease progression, as assessed by the Investigator using RECIST v1.1

    Time frame: 6 months after start of treatment

06

Study locations

1 site
  • Cochin Hospital
    Paris, 75014, France
07

Registry details

Key details

Study ID
NCT04879316
Lead sponsor
Hôpital Cochin
Collaborators
Assistance Publique - Hôpitaux de Paris
Responsible party
Camille Levalois (Co-investigator, Hôpital Cochin) — Principal investigator
First posted
May 10, 2021
Start date
Aug 1, 2016
Primary completion
Oct 1, 2019
Completion
Apr 30, 2020
Last update
May 12, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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