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出境医 / 临床实验 / Evolution of the Physical Condition in Treated Cancer Patients (PROTECT-01)
Evolution of the Physical Condition in Treated Cancer Patients (PROTECT-01)
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 |
|---|---|---|
| Non-small Cell Lung Cancer Metastatic Breast Cancer Female Colon Cancer | Other: Adaptated Physical Activity | Not Applicable |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 300 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Supportive Care |
| Official Title: | Evolution of the Physical Condition in Treated Cancer Patients |
| Actual Study Start Date : | September 17, 2019 |
| Estimated Primary Completion Date : | September 17, 2020 |
| Estimated Study Completion Date : | June 1, 2021 |
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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
- Patient without contraindication to the study-specific assessments
- Eastern Cooperative Oncology Group ≤ 2
- Age ≥ 18 years old
- Life expectancy > 6 months
- Able to speak, read and understand French
- Written informed consent obtained from the patient
- Registration in a national health care system
Exclusion Criteria:
- Patient with psychiatric, neurologic or musculoskeletal disorders
- Pregnant or breastfeeding women
- Minor or protected adult
Contacts and Locations
Contacts
| Contact: Valerie SARTORI | +33 388 25 85 41 | vsartori@strasbourg.unicancer.fr | |
| Contact: Joris MALLARD | + 33 388 25 85 68 | jmallard@strasbourg.unicancer.fr |
Locations
| France | |
| Centre Paul Strauss | Recruiting |
| Strasbourg, France, 67200 | |
| Contact: SARTORI Valérie +33 368 76 72 23 v.sartori@icans.eu | |
Sponsors and Collaborators
Centre Paul Strauss
Investigators
| Principal Investigator: | Roland SCHOTT, Md | Centre Paul Strauss |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 18, 2019 | ||||||||
| First Posted Date ICMJE | May 21, 2019 | ||||||||
| Last Update Posted Date | February 11, 2020 | ||||||||
| Actual Study Start Date ICMJE | September 17, 2019 | ||||||||
| Estimated Primary Completion Date | September 17, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
evolution of exercise tolerance [ Time Frame: 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.
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
|
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Evolution of the Physical Condition in Treated Cancer Patients | ||||||||
| Official Title ICMJE | Evolution of the Physical Condition in Treated Cancer Patients | ||||||||
| 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. |
||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Supportive Care |
||||||||
| Condition ICMJE |
|
||||||||
| Intervention ICMJE | 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)
|
||||||||
| Study Arms ICMJE | Experimental: experimental: observational cohort
Evaluation of the physical condition and the quality of life
Intervention: Other: Adaptated Physical Activity
|
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| Publications * | Mallard J, Hucteau E, Schott R, Petit T, Demarchi M, Belletier C, Ben Abdelghani M, Carinato H, Chiappa P, Fischbach C, Kalish-Weindling M, Bousinière A, Dufour S, Favret F, Pivot X, Hureau TJ, Pagano AF. Evolution of Physical Status From Diagnosis to the End of First-Line Treatment in Breast, Lung, and Colorectal Cancer Patients: The PROTECT-01 Cohort Study Protocol. Front Oncol. 2020 Aug 7;10:1304. doi: 10.3389/fonc.2020.01304. eCollection 2020. | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
300 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | June 1, 2021 | ||||||||
| Estimated Primary Completion Date | September 17, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
|
||||||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
|
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| Listed Location Countries ICMJE | France | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03956641 | ||||||||
| Other Study ID Numbers ICMJE | 2019-001 2019-A00848-49 ( Other Identifier: ANSM ) |
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| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | Centre Paul Strauss | ||||||||
| Study Sponsor ICMJE | Centre Paul Strauss | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
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| PRS Account | Centre Paul Strauss | ||||||||
| Verification Date | February 2020 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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