Energy for Lymphocytes (ELY)

Hôpital Cochin

Status: Completed

Conditions: Progression, Disease; Non-small Cell Lung Cancer

Treatments: Other: Resting Energy Expenditure measurement

Study type: Observational

Funder types: Other

Identifiers

NCT04879316

HCochin

Details and patient eligibility

About

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.

Enrollment: 144 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

• 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.

Trial design

144 participants in 1 patient group

adult patients with NSCLC initiating nivolumab or pembrolizumab

Description:

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.

Treatment:

Other: Resting Energy Expenditure measurement