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

Léon Bérard Center

Status: Completed

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Other: Exercise arm :

Study type: Interventional

Funder types: Other

Identifiers

NCT04676009

ET20000185 (Other Identifier)

ERICA

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

Exercise arm :

Experimental group

Description:

Patient randomized to the Exercise arm will receive physical activity recommendations at inclusion and nutritional assessment will be carried out during the first and last treatment cure. Patients will receive an acute physical exercise just before immunotherapy and chemotherapy infusion.They will have a home walking program and will have to wear an activity tracker during the 3 months of intervention. 3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place before exercise (1), after exercise (2) and 12 hours after the start of treatment (3).

Treatment:

Other: Exercise arm :

Control arm

No Intervention group

Description:

Patients will receive physical activity recommendations at inclusion and a nutritional assessment will be carried out during the first and last treatment cure. They will receive the usual care and standard treatment protocol (immunotherapy and chemotherapy). 3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment (3).