Carcinoma, Non-Small-Cell LungERICANCT04676009
Feasibility of an Acute Physical Exercise Before Treatment Infusion for Metastatic Lung Cancer Patients
A study testing Exercise arm : in people with Carcinoma, Non-Small-Cell Lung, run by Centre Leon Berard at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Exercise arm :
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jan 2021to 11 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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
Who cannot join
- 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),
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of an Acute Physical Exercise Before Immunotherapy and Chemotherapy Infusion for Metastatic Non-small-cell Lung Cancer Patients: Protocol ERICA Study
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
- Being tested
- Exercise arm :
- Keywords
- Lung Cancer, Lung Neoplasm, Metastasis, Acute exercise, Immunotherapy, Connected devices
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise arm :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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise arm : | Experimental | 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). Receives: Other: Exercise arm : |
| Control arm | No intervention | 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigate the feasibility of an acute physical exercise during the immunotherapy/chemotherapy preinfusion
Ratio of the number of acute physical exercise sessions immunotherapy/chemotherapy preinfusion performed by"exercise" group patient / number of acute physical exercise sessions planned
Measured: 3 months
Secondary outcomes (49)
Investigate the physical activity fitness (sub-maximum endurance test)
Sub-maximum endurance test on an ergocycle
Measured: Baseline, 3 months
Investigate the lower strength muscular function change
Maximum isometric force of the knee extensors
Measured: Baseline, 3 months, 6 months
Investigate the maximum isometric upper limb strength change
Hand dynamometer
Measured: Baseline, 3 months, 6 months
Investigate the Physical Activity level change
The PA level will be measured by the Godin Leisure-Time Physical Activity Questionnaire (GLTAPQ). The GLTAPQ is a 4-item self-administered questionnaire with the first three questions designed to obtain information on the number of times an individual engages in light, moderate and intense "leisure-time PA" periods of at least 15 minutes during a typical week. The scoring of the GSLTPAQ is the "LSI" (Leisure Score Index) is obtained using the following formula: (light PA frequency × 3) + (moderate PA frequency × 5) + (vigorous PA frequency × 9). People with a moderate to high LSI ≥ 24 are classified as active, while people reporting a moderate to high LSI ≤ 23 are classified as insufficiently active (estimated energy expenditure < 14 Kcal/kg/week).
Measured: Baseline, 3 months, 6 months
Investigate the patient anthropometrics change
Weight in kilograms
Measured: Baseline, 3 months, 6 months
Investigate the patient anthropometrics change
Hip circumference in centimeters
Measured: Baseline, 3 months, 6 months
Investigate the patient anthropometrics change
Waist circumference in centimeters
Measured: Baseline, 3 months, 6 months
Investigate the patient anthropometrics change
BMI (weight/height²)
Measured: Baseline, 3 months, 6 months
Investigate the patient health-related quality of life change
Quality of life will be measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality Of Life Questionnaire (QLQ-C30). Quality of life specific to lung cancer will be assessed by the 13-item module: The Quality Of Life Questionnaire - Lung Cancer 13 (QLQ-LC13). The QLQ-LC13 self-questionnaire is an additional measure of the symptoms and side effects experienced by lung cancer patients who receive non-surgical treatment.
Measured: Baseline, 3 months, 6 months
Investigate the patient health-related quality of life specific to lung cancer change
Quality of life specific to lung cancer will be assessed by the 13-item module: The Quality Of Life Questionnaire - Lung Cancer 13 (QLQ-LC13). The QLQ-LC13 self-questionnaire is an additional measure of the symptoms and side effects experienced by lung cancer patients who receive non-surgical treatment.
Measured: Baseline, 3 months, 6 months
Investigate the fatigue change
Fatigue will be assessed by the EORTC-QLQ module measuring cancer-related fatigue (EORTC QLQ-FA12). This self-questionnaire includes 12 items that assess physical, cognitive and emotional fatigue related to cancer. Participants will respond on a Likert scale ranging from "not at all" to "a lot". All scores will be transformed into a scale from 0 to 100, with a higher score indicating a higher degree of fatigue.
Measured: Baseline, 3 months, 6 months
Investigate the sleep quality change
The perceived quality of sleep is assessed by the Insomnia Severity Index (ISI) which measures the severity of insomnia. The questionnaire consists of 7 items rated on a 5-point scale ranging from 0 ("none") to 4 ("very severe"). This self-questionnaire makes it possible to evaluate the severity of the patient's sleep difficulties (initial, maintenance, morning insomnia), the degree of sleep dissatisfaction, the level of interference with daily functioning, the degree of appearance of sleep difficulties and the level of anxiety related to insomnia. The total score of the items varies between 0 and 28. A high score indicates greater sleep difficulties.
Measured: Baseline, 3 months, 6 months
Investigate the impact of social vulnerability
Social vulnerability will be assessed by the EPICES score (Evaluation de la Précarité et des Inégalités de santé dans les Centres d'Examens de Santé). By adding up the points of the 11 binary questions ("Yes"/"No") of the self-questionnaire we obtain the so-called EPICES score. This quantitative score varies from 0 "no precariousness" to 100 "highest precariousness".
Measured: Baseline
Investigate the muscle mass and sarcopenia
CT scans
Measured: Baseline, 3 months, 6 months
Investigate the immune biomarkers change
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
The following immune biomarkers will be assay : Natural Killer cells, B lymphocytes, T lymphocytes, monocytes, sub-populations of dendritic cells on frozen PBMC
Measured: Baseline and 3 months
Investigate the Activin change (inflammation biomarkers)
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Measured: Baseline and 3 months
Investigate the TNF-alpha change (inflammation biomarkers)
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Measured: Baseline and 3 months
Investigate the IL-1béta change (inflammation biomarkers)
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Measured: Baseline and 3 months
Investigate the IL-6 change (inflammation biomarkers)
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Measured: Baseline and 3 months
Investigate the Follistatin (inflammation biomarkers)
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Measured: Baseline and 3 months
Investigate the GDF5 (BMP14) (inflammation biomarkers)
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Measured: Baseline and 3 months
Investigate the GDF15 (inflammation biomarkers)
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Measured: Baseline and 3 months
Investigate the IL-10 (inflammation biomarkers)
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Measured: Baseline and 3 months
Investigate the IL-15 (inflammation biomarkers)
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Measured: Baseline and 3 months
Investigate the NH3 (inflammation biomarkers)
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Measured: Baseline and 3 months
Investigate the Aminogramme (inflammation biomarkers)
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Measured: Baseline and 3 months
Investigate the CRP (inflammation biomarkers)
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Measured: Baseline and 3 months
Investigate the IFN-gamma change (inflammation biomarkers)
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Measured: Baseline and 3 months
Investigate the Cortisol change (inflammation biomarkers)
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Measured: Baseline and 3 months
Investigate the Myostatin change (inflammation biomarkers)
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Measured: Baseline and 3 months
Investigate the Advanced oxidation protein products (AOPP) change
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Measured: Baseline and 3 months
Investigate the Superoxide dismutase (SOD) change
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Measured: Baseline and 3 months
Investigate the catalase (CAT) change
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Measured: Baseline and 3 months
Investigate the malondialdehyde (MDA) change
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
The following biomarkers will be assay : Advanced oxidation protein products (AOPP), malondialdehyde (MDA), Superoxide dismutase (SOD), catalase (CAT), glutathione peroxidase (GPX), Xanthine oxidase (XO), and Myeloperoxidase (MPO).
Measured: Baseline and 3 months
Investigate the glutathione peroxidase (GPX) change
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
The following biomarkers will be assay : Advanced oxidation protein products (AOPP), malondialdehyde (MDA), Superoxide dismutase (SOD), catalase (CAT), glutathione peroxidase (GPX), Xanthine oxidase (XO), and Myeloperoxidase (MPO).
Measured: Baseline and 3 months
Investigate the Xanthine Myeloperoxidase (MPO) change
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
The following biomarkers will be assay : Advanced oxidation protein products (AOPP), malondialdehyde (MDA), Superoxide dismutase (SOD), catalase (CAT), glutathione peroxidase (GPX), Xanthine oxidase (XO), and Myeloperoxidase (MPO).
Measured: Baseline and 3 months
Investigate the Xanthine oxidase (XO) change
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
The following biomarkers will be assay : Advanced oxidation protein products (AOPP), malondialdehyde (MDA), Superoxide dismutase (SOD), catalase (CAT), glutathione peroxidase (GPX), Xanthine oxidase (XO), and Myeloperoxidase (MPO).
Measured: Baseline and 3 months
Proportion of patients who have severe toxicity (grade >2)
Occurence of severe toxicity (grade > 2) according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE). Number of delayed or cancelled treatment sessions and relative dose-intensity (RDI) for patients with grade ≥ 3 chemotherapy-related toxicities, calculated as the ratio of the "delivered" dose-intensity to the "expected" dose-intensity.
Measured: Up to 3 months
Progression free survival
Period from the date of randomization to the date of event defined as disease progression or death from any cause
Measured: 6 months
Acceptability of the study
Ratio of the number of patients included / number of eligible patients
Measured: 3 months
Tracker activity acceptability
Number of days the activity tracker is worn / number of days in the programme
Measured: 3 months
Safety of the intervention
Number, type and timing of adverse events due to program
Measured: 3 months
Adherence of the intervention
number of steps at home realized / number of steps at home prescribed (only in the intervention arm)
Measured: 3 months and 6 months
Investigate the Physical Activity level change
Daily number of step prescription (only in the intervention arm)
Measured: Baseline, 3 months and 6 months
Investigate the glucose change
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Measured: Baseline and 3 months
Investigate the insulin change
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Measured: Baseline and 3 months
Investigate the lactat change
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Measured: Baseline and 3 months
Investigate the PCR change
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Measured: Baseline and 3 months
Investigate the HIF-1 change
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start21 Jan 2021
- Primary completion31 Dec 2023
- Study completion11 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Collaborators
- Claude Bernard University, Cancer Research Center of Lyon, Hospices Civils de Lyon, Inter-university Laboratory of Human Movement Biology
- Responsible party
- Sponsor
- Investigators
- Maurice Pérol, MD, Principal investigator, Centre Leon Berard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04676009
- Sponsor's protocol ID
- ERICA
- Other IDs
- ET20000185
- Acronym
- ERICA
- Status last verified
- Feb 2024
- First submitted
- 8 Dec 2020
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35393316
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of an Acute Physical Exercise Before Immunotherapy and Chemotherapy Infusion for Metastatic Non-small-cell Lung Cancer Patients: Protocol ERICA Study
- ClinicalTrials.gov ID
- NCT04676009
- Acronym / sponsor ID
- ERICA / ERICA
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Lung Cancer, Lung Neoplasm, Metastasis, Acute exercise, Immunotherapy, Connected devices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Collaborators
- Claude Bernard University, Cancer Research Center of Lyon, Hospices Civils de Lyon, Inter-university Laboratory of Human Movement Biology
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 11 Jan 2024 (actual)
- First posted
- 19 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise arm : | Experimental | Other: 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). |
| Control arm | No intervention | –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). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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,
Key exclusion criteria (13 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Exercise arm : |
Primary outcome
Investigate the feasibility of an acute physical exercise during the immunotherapy/chemotherapy preinfusion
Time frame: 3 months
Ratio of the number of acute physical exercise sessions immunotherapy/chemotherapy preinfusion performed by"exercise" group patient / number of acute physical exercise sessions planned
49 secondary outcomes
Investigate the physical activity fitness (sub-maximum endurance test)
Time frame: Baseline, 3 months
Investigate the lower strength muscular function change
Time frame: Baseline, 3 months, 6 months
Investigate the maximum isometric upper limb strength change
Time frame: Baseline, 3 months, 6 months
Investigate the Physical Activity level change
Time frame: Baseline, 3 months, 6 months
Investigate the patient anthropometrics change
Time frame: Baseline, 3 months, 6 months
Investigate the patient anthropometrics change
Time frame: Baseline, 3 months, 6 months
Investigate the patient anthropometrics change
Time frame: Baseline, 3 months, 6 months
Investigate the patient anthropometrics change
Time frame: Baseline, 3 months, 6 months
Investigate the patient health-related quality of life change
Time frame: Baseline, 3 months, 6 months
Investigate the patient health-related quality of life specific to lung cancer change
Time frame: Baseline, 3 months, 6 months
Investigate the fatigue change
Time frame: Baseline, 3 months, 6 months
Investigate the sleep quality change
Time frame: Baseline, 3 months, 6 months
Investigate the impact of social vulnerability
Time frame: Baseline
Investigate the muscle mass and sarcopenia
Time frame: Baseline, 3 months, 6 months
Investigate the immune biomarkers change
Time frame: Baseline and 3 months
Investigate the Activin change (inflammation biomarkers)
Time frame: Baseline and 3 months
Investigate the TNF-alpha change (inflammation biomarkers)
Time frame: Baseline and 3 months
Investigate the IL-1béta change (inflammation biomarkers)
Time frame: Baseline and 3 months
Investigate the IL-6 change (inflammation biomarkers)
Time frame: Baseline and 3 months
Investigate the Follistatin (inflammation biomarkers)
Time frame: Baseline and 3 months
Investigate the GDF5 (BMP14) (inflammation biomarkers)
Time frame: Baseline and 3 months
Investigate the GDF15 (inflammation biomarkers)
Time frame: Baseline and 3 months
Investigate the IL-10 (inflammation biomarkers)
Time frame: Baseline and 3 months
Investigate the IL-15 (inflammation biomarkers)
Time frame: Baseline and 3 months
Investigate the NH3 (inflammation biomarkers)
Time frame: Baseline and 3 months
Investigate the Aminogramme (inflammation biomarkers)
Time frame: Baseline and 3 months
Investigate the CRP (inflammation biomarkers)
Time frame: Baseline and 3 months
Investigate the IFN-gamma change (inflammation biomarkers)
Time frame: Baseline and 3 months
Investigate the Cortisol change (inflammation biomarkers)
Time frame: Baseline and 3 months
Investigate the Myostatin change (inflammation biomarkers)
Time frame: Baseline and 3 months
Investigate the Advanced oxidation protein products (AOPP) change
Time frame: Baseline and 3 months
Investigate the Superoxide dismutase (SOD) change
Time frame: Baseline and 3 months
Investigate the catalase (CAT) change
Time frame: Baseline and 3 months
Investigate the malondialdehyde (MDA) change
Time frame: Baseline and 3 months
Investigate the glutathione peroxidase (GPX) change
Time frame: Baseline and 3 months
Investigate the Xanthine Myeloperoxidase (MPO) change
Time frame: Baseline and 3 months
Investigate the Xanthine oxidase (XO) change
Time frame: Baseline and 3 months
Proportion of patients who have severe toxicity (grade >2)
Time frame: Up to 3 months
Progression free survival
Time frame: 6 months
Acceptability of the study
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Derived from this study: PubMed 35393316Gouez 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maurice Pérol, MD principal investigator
Centre Leon Berard
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise arm : in people with Carcinoma, Non-Small-Cell Lung, run by Centre Leon Berard at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigate the feasibility of an acute physical exercise during the immunotherapy/chemotherapy preinfusion (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04676009, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.