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

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Updated on 22 December 2021

See if I qualify

pemetrexed

carboplatin

pembrolizumab

EGFR

cancer chemotherapy

targeted therapy

lung carcinoma

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	Carcinoma, Non-Small-Cell Lung
Treatment	Exercise arm :
Clinical Study Identifier	NCT04676009
Sponsor	Centre Leon Berard
Last Modified on	22 December 2021

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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 or Carboplatin and Pemetrexed or Taxol and Carboplatin), 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 ≤ 2
	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
	Personal history or co-existence of another primary cancer (except of in situ cancer regardless of the site and/or basal cell skin cancer and/or cancer in complete remission for more than 5 years)
	Having severe undernutrition defined according to the Haute Autorité de Santé (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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Feasibility of an Acute Physical Exercise Before Treatment Infusion for Metastatic Lung Cancer Patients