Feasibility of an Acute Physical Exercise Before Treatment Infusion for Metastatic Lung Cancer Patients

  • STATUS
    Recruiting
  • End date
    Dec 10, 2022
  • participants needed
    30
  • sponsor
    Centre Leon Berard
Updated on 24 February 2021

Summary

Because of metastatic Non-Small Cell Lung Cancer (mNSCLC) and its treatments, patients suffer from numerous symptoms such as dyspnea, muscle atrophy, pain, fatigue, loss of appetite, altered physical condition and lung function, which may further impair the patient's overall condition. Nevertheless, it has been suggested that physical exercise could improve response to treatment at the clinical level due to its known effects on the immune system. Moreover, preclinical studies have shown that exercise performed during chemotherapy administration could result in physiological benefits such as improved intra-tumoral infusion and drug delivery. The ERICA study aims to assess the feasibility of an acute physical exercise immediately before immunotherapy and chemotherapy administration in patients with mNSCLC.

Details
Condition Non-Small Cell Lung Cancer
Treatment Exercise arm :
Clinical Study IdentifierNCT04676009
SponsorCentre Leon Berard
Last Modified on24 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age between 18 and 80 years old
Having a newly metastatic non-small-cell lung cancer (NSCLC) without an EGFR/ALK alteration diagnosis
Being scheduled to receive a 1st line intravenous chemotherapy (Cisplatin and Pemetrexed), and immunotherapy (monoclonal anti-PD-1 and anti-PD-L1 antibodies : Pembrolizumab) treatment NB : patients who have previously received one or more treatments other than chemotherapy (e.g. targeted therapy) and must start their first chemotherapy are eligible
Treated in Centre Leon Berard
Having an Eastern Co-operative Oncology Group (ECOG) performance status of 0-1
Being voluntary and available to get involved throughout the study duration
Being able to engage in Physical Activity with a medical certificate attested by one of the investigators clinical oncologist or the referring oncologist
Affiliated with a social security scheme
Having dated and signed an informed consent
Able to read, write and understand French

Exclusion Criteria

Patient with unstable bone metastases or unconsolidated pathologic fractures, Having a central nervous system impairment with neurological disorder avoids the physical exercise practice on a cycle ergometry
Having severe undernutrition defined according to the Haute Autorit de Sant (i.e. , for an adult aged 18 years and < 70 : BIM 17 or weight loss 10% in 1 month or 15% in 6 months or 15% compared to the usual weight before the disease diagnosis or albuminemia < 30 g/l ; for an adult aged 70 years : BIM < 18 or weight loss 10% in 1 month or 15% in 6 months or an albuminemia < 30 g/l)
Having a severe amenia (hemoglobin 8 g/dl) during the 30 last days prior inclusion
Presenting cardiovascular history or any cardiovascular risk: chronic coronary (or poorly balanced), artery disease, cardiac arrhythmia, symptomatic heart disease, uncontrolled or untreated hypertension, heart attack diagnosed within the last 6 months, coronary angioplasty with or without stent less than 6 months old, coronary artery bypass surgery less than 12 months old, history of poorly balanced type 2 diabetes
In case of diabetes: Glycated hemoglobin (HbA1c) > 7% (in the last 3 months)
Stage IV Chronic Obstructive Pulmonary Disease (FEV1 < 30%)
Patient with a contraindication to the proposed physical exercise in the study (orthopedic disorder likely to impede walking and pedaling such as disabling coxarthrosis or gonarthrosis, operated or not)
Already included in a PA study
Cannot be followed for medical, social, family, geographical or psychological reasons, for the duration of the intervention (3 months) and then for the duration of the post-intervention follow-up (3 months)
Patient under legal protection measure (under guardianship, curatorship, safeguard of justice)
Deprived of liberty by judicial or administrative decision
Pregnant patient
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