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

NCT ID: NCT04676009

Last Updated: 2024-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-21
• Study Completion Date: 2024-01-11

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Exercise arm :

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).

Group Type: EXPERIMENTAL

Exercise arm :

Intervention Type: OTHER

Patients will receive physical activity recommendations at inclusion.

At each treatment cure, patients will receive pre-exercise nutritional recommendations and an acute physical exercise prior to immunotherapy and chemotherapy. The acute physical exercise will last 35 minutes and will be intermittent and individualized based on the results obtained by the patient during an endurance test on a ergocyle performed prior to treatment.

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).

A nutritional assessment will be carried out during the first and last treatment cure.

They will also benefit a home walking program. These patients will have to wear an activity tracker tracker during all intervention (3 months).

They will have a phone follow-up every 10 days (± 3 days) after each treatment cure for the study duration.

Control arm

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise arm :

Patients will receive physical activity recommendations at inclusion.

At each treatment cure, patients will receive pre-exercise nutritional recommendations and an acute physical exercise prior to immunotherapy and chemotherapy. The acute physical exercise will last 35 minutes and will be intermittent and individualized based on the results obtained by the patient during an endurance test on a ergocyle performed prior to treatment.

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).

A nutritional assessment will be carried out during the first and last treatment cure.

They will also benefit a home walking program. These patients will have to wear an activity tracker tracker during all intervention (3 months).

They will have a phone follow-up every 10 days (± 3 days) after each treatment cure for the study duration.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Claude Bernard University

OTHER

Sponsor Role: collaborator

Lyon Cancer Research Centre

UNKNOWN

Sponsor Role: collaborator

Hospices Civils de Lyon

OTHER

Sponsor Role: collaborator

Inter-university Laboratory of Human Movement Biology

UNKNOWN

Sponsor Role: collaborator

Centre Leon Berard

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maurice Pérol, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Leon Berard

Locations

Centre Léon Bérard

Lyon, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 35393316 (View on PubMed)

Other Identifiers

ET20000185

Identifier Type: OTHER

Identifier Source: secondary_id

ERICA

Identifier Type: -

Identifier Source: org_study_id