Clinical trial NCT04676009: Feasibility of an Acute Physical Exercise Before Treatment Infusion for Metastatic Lung Cancer Patients
Official title: Feasibility of an Acute Physical Exercise Before Immunotherapy and Chemotherapy Infusion for Metastatic Non-small-cell Lung Cancer Patients: Protocol ERICA Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Lung Cancer
Lung Neoplasm
Metastasis
Acute exercise
Immunotherapy
Connected devices
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
Collaborators: name: Claude Bernard University
name: Lyon Cancer Research Centre
name: Hospices Civils de Lyon
name: Inter-university Laboratory of Human Movement Biology
First posted: 2020-12-19
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Investigate the feasibility of an acute physical exercise during the immunotherapy/chemotherapy preinfusion
timeFrame: 3 months
Secondary outcomes:
measure: Investigate the physical activity fitness (sub-maximum endurance test)
timeFrame: Baseline, 3 months
measure: Investigate the lower strength muscular function change
timeFrame: Baseline, 3 months, 6 months
measure: Investigate the maximum isometric upper limb strength change
timeFrame: Baseline, 3 months, 6 months
measure: Investigate the Physical Activity level change
timeFrame: Baseline, 3 months, 6 months
measure: Investigate the patient anthropometrics change
timeFrame: Baseline, 3 months, 6 months
measure: Investigate the patient anthropometrics change
timeFrame: Baseline, 3 months, 6 months
measure: Investigate the patient anthropometrics change
timeFrame: Baseline, 3 months, 6 months
measure: Investigate the patient anthropometrics change
timeFrame: Baseline, 3 months, 6 months
measure: Investigate the patient health-related quality of life change
timeFrame: Baseline, 3 months, 6 months
measure: Investigate the patient health-related quality of life specific to lung cancer change
timeFrame: Baseline, 3 months, 6 months
measure: Investigate the fatigue change
timeFrame: Baseline, 3 months, 6 months
measure: Investigate the sleep quality change
timeFrame: Baseline, 3 months, 6 months
measure: Investigate the impact of social vulnerability
timeFrame: Baseline
measure: Investigate the muscle mass and sarcopenia
timeFrame: Baseline, 3 months, 6 months
measure: Investigate the immune biomarkers change
timeFrame: Baseline and 3 months
measure: Investigate the Activin change (inflammation biomarkers)
timeFrame: Baseline and 3 months
measure: Investigate the TNF-alpha change (inflammation biomarkers)
timeFrame: Baseline and 3 months
measure: Investigate the IL-1béta change (inflammation biomarkers)
timeFrame: Baseline and 3 months
measure: Investigate the IL-6 change (inflammation biomarkers)
timeFrame: Baseline and 3 months
measure: Investigate the Follistatin (inflammation biomarkers)
timeFrame: Baseline and 3 months
measure: Investigate the GDF5 (BMP14) (inflammation biomarkers)
timeFrame: Baseline and 3 months
measure: Investigate the GDF15 (inflammation biomarkers)
timeFrame: Baseline and 3 months
measure: Investigate the IL-10 (inflammation biomarkers)
timeFrame: Baseline and 3 months
measure: Investigate the IL-15 (inflammation biomarkers)
timeFrame: Baseline and 3 months
measure: Investigate the NH3 (inflammation biomarkers)
timeFrame: Baseline and 3 months
measure: Investigate the Aminogramme (inflammation biomarkers)
timeFrame: Baseline and 3 months
measure: Investigate the CRP (inflammation biomarkers)
timeFrame: Baseline and 3 months
measure: Investigate the IFN-gamma change (inflammation biomarkers)
timeFrame: Baseline and 3 months
measure: Investigate the Cortisol change (inflammation biomarkers)
timeFrame: Baseline and 3 months
measure: Investigate the Myostatin change (inflammation biomarkers)
timeFrame: Baseline and 3 months
measure: Investigate the Advanced oxidation protein products (AOPP) change
timeFrame: Baseline and 3 months
measure: Investigate the Superoxide dismutase (SOD) change
timeFrame: Baseline and 3 months
measure: Investigate the catalase (CAT) change
timeFrame: Baseline and 3 months
measure: Investigate the malondialdehyde (MDA) change
timeFrame: Baseline and 3 months
measure: Investigate the glutathione peroxidase (GPX) change
timeFrame: Baseline and 3 months
measure: Investigate the Xanthine Myeloperoxidase (MPO) change
timeFrame: Baseline and 3 months
measure: Investigate the Xanthine oxidase (XO) change
timeFrame: Baseline and 3 months
measure: Proportion of patients who have severe toxicity (grade >2)
timeFrame: Up to 3 months
measure: Progression free survival
timeFrame: 6 months
measure: Acceptability of the study
timeFrame: 3 months
measure: Tracker activity acceptability
timeFrame: 3 months
measure: Safety of the intervention
timeFrame: 3 months
measure: Adherence of the intervention
timeFrame: 3 months and 6 months
measure: Investigate the Physical Activity level change
timeFrame: Baseline, 3 months and 6 months
measure: Investigate the glucose change
timeFrame: Baseline and 3 months
measure: Investigate the insulin change
timeFrame: Baseline and 3 months
measure: Investigate the lactat change
timeFrame: Baseline and 3 months
measure: Investigate the PCR change
timeFrame: Baseline and 3 months
measure: Investigate the HIF-1 change
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre Léon Bérard
Study officials:
affiliation: Centre Leon Berard
name: Maurice Pérol, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gouez M, Perol O, Perol M, Caux C, Menetrier-Caux C, Villard M, Walzer T, Delrieu L, Saintigny P, Marijnen P, Pialoux V, Fervers B. Effect of acute aerobic exercise before immunotherapy and chemotherapy infusion in patients with metastatic non-small-cell lung cancer: protocol for the ERICA feasibility trial. BMJ Open. 2022 Apr 7;12(4):e056819. doi: 10.1136/bmjopen-2021-056819.