Status:
COMPLETED
Feasibility of an Acute Physical Exercise Before Treatment Infusion for Metastatic Lung Cancer Patients
Lead Sponsor:
Centre Leon Berard
Collaborating Sponsors:
Claude Bernard University
Lyon Cancer Research Centre
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18-80 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 11 2024
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04676009
Start Date
January 21 2021
End Date
January 11 2024
Last Update
February 21 2024
Active Locations (1)
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1
Centre Léon Bérard
Lyon, France, 69008