PROTECT-01: Evolution of the Physical Condition in Treated Cancer Patients
Study Details
Study Description
Brief Summary
Adaptated Physical Activity (APA) during treatment of cancer is one of the actual global health recommendation because of the benefits observed in several parameters evaluated in many clinical studies. A best knowledge of the physical and medical characteristics of patients, including type of cancer and type of treatment, is primordial to optimize the patient care and the effectiveness of APA programs.
Descriptive, explorative and prospective study of 3 different populations:
One population with locally advanced or metastatic non-small cell lung cancer treated with multiple therapeutic lines. Two different populations of early cancer patients and treated with a platinum-based regimen for colon cancer and a taxane-based chemotherapy for breast cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: experimental: observational cohort Evaluation of the physical condition and the quality of life |
Other: Adaptated Physical Activity
Evaluation of the physical condition and the quality of life during the course of treatment (after 8 weeks of treatment) and at the end of the treatment's line (except for breast cancer patients)
|
Outcome Measures
Primary Outcome Measures
- evolution of exercise tolerance [change from baseline exercise tolerance at 12 weeks after the end of the treatment]
To describe exercise tolerance, by a six-minute walk test, in patients treated for a cancer (of lung, breast or colon) after 8 weeks of treatment.
Secondary Outcome Measures
- measurement of parameters reflecting the physical condition [change from baseline physical condition at 12 weeks after the end of the treatment]
To describe objective and felt fatigue by Fonctional assessment of chronic illness therapy-fatique (41 items scale)
- measurement of parameters reflecting the physical condition [change from baseline physical condition at 12 weeks after the end of the treatment]
To describe muscular strenght by FPmax: Maximal strenght of finger flexors; (measured in Newton with a dynamometer)
- measurement of parameters reflecting the physical condition [change from baseline physical condition at 12 weeks after the end of the treatment]
To describe muscular strenght by IFP: Fatigability indexof finger flexors; (measured in Newton with a dynamometer)
- measurement of parameters reflecting the physical condition [change from baseline physical condition at 12 weeks after the end of the treatment]
To describe muscular strenght by FIEmax: Maximal isometric strenght of knee extensors; (measured in Newton with a dynamometer)
- measurement of parameters reflecting the physical condition [change from baseline physical condition at 12 weeks after the end of the treatment]
To describe muscular strenght by IFE: Fatigability index of knee extensors; (measured in Newton with a dynamometer)
- measurement of the lean body mass condition [change from baseline physical condition at 12 weeks after the end of the treatment]
To describe lean body mass by impedancemeter
- measurement of the pulmonary function [change from baseline physical condition at 12 weeks after the end of the treatment]
Spirometry measures lung function, specifically the amount (volume) of air that can be inhaled and exhaled
- measurement of parameters reflecting the physical condition [change from baseline physical condition at 12 weeks after the end of the treatment]
To describe anxiety by Hospital Anxiety and Depression scale (14 items)
- measurement of parameters reflecting the physical condition [change from baseline physical condition at 12 weeks after the end of the treatment]
To describe physical activity level by by Global Physical Activity questionnaire
- measurement of parameters reflecting the physical condition [change from baseline physical condition at 12 weeks after the end of the treatment]
To describe physical performance index by Short Physical Performance Battery which is a group of measures that combines the results of the gait speed
- measurement of parameters reflecting the physical condition [change from baseline physical condition at 12 weeks after the end of the treatment]
To describe physical performance index by Short Physical Performance Battery which is a group of measures that combines the results of the chair stand
- measurement of parameters reflecting the physical condition [change from baseline physical condition at 12 weeks after the end of the treatment]
To describe physical performance index by Short Physical Performance Battery which is a group of measures that combines the results of the balance tests
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Woman with breast cancer treated with adjuvant chemotherapy (taxane) or patient with colon cancer treated with adjuvant regimen (FOLFOX) or patient with locally advanced or metastatic lung cancer
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Patient without contraindication to the study-specific assessments
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Eastern Cooperative Oncology Group ≤ 2
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Age ≥ 18 years old
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Life expectancy > 6 months
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Able to speak, read and understand French
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Written informed consent obtained from the patient
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Registration in a national health care system
Exclusion Criteria:
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Patient with psychiatric, neurologic or musculoskeletal disorders
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Pregnant or breastfeeding women
-
Minor or protected adult
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre Paul Strauss | Strasbourg | France | 67200 |
Sponsors and Collaborators
- Centre Paul Strauss
Investigators
- Principal Investigator: Roland SCHOTT, Md, Centre Paul Strauss
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2019-001
- 2019-A00848-49