Non-small Cell Lung Cancer MetastaticPROTECT-01NCT03956641
Evolution of the Physical Condition in Treated Cancer Patients
A study testing Adaptated Physical Activity in people with Non-small Cell Lung Cancer Metastatic and Breast Cancer Female, run by Centre Paul Strauss at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer Metastatic, Breast Cancer Female, Colon Cancer
- What is being tested?
- Adaptated Physical Activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 17 Sep 2019to 1 Jun 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient with psychiatric, neurologic or musculoskeletal disorders
- Pregnant or breastfeeding women
- Minor or protected adult
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Paul Strauss
Strasbourg, 67200
SARTORI Valérie, +33 368 76 72 23, v.sartori@icans.eu
About this study
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.
- Being tested
- Adaptated Physical Activity
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptated Physical ActivityOther
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 group | Role | What they receive |
|---|---|---|
| experimental: observational cohort | Experimental | Evaluation of the physical condition and the quality of life Receives: Other: Adaptated Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
evolution of exercise tolerance
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.
Measured: change from baseline exercise tolerance at 12 weeks after the end of the treatment
Secondary outcomes (12)
measurement of parameters reflecting the physical condition
To describe objective and felt fatigue by Fonctional assessment of chronic illness therapy-fatique (41 items scale)
Measured: change from baseline physical condition at 12 weeks after the end of the treatment
measurement of parameters reflecting the physical condition
To describe muscular strenght by FPmax: Maximal strenght of finger flexors; (measured in Newton with a dynamometer)
Measured: change from baseline physical condition at 12 weeks after the end of the treatment
measurement of parameters reflecting the physical condition
To describe muscular strenght by IFP: Fatigability indexof finger flexors; (measured in Newton with a dynamometer)
Measured: change from baseline physical condition at 12 weeks after the end of the treatment
measurement of parameters reflecting the physical condition
To describe muscular strenght by FIEmax: Maximal isometric strenght of knee extensors; (measured in Newton with a dynamometer)
Measured: change from baseline physical condition at 12 weeks after the end of the treatment
measurement of parameters reflecting the physical condition
To describe muscular strenght by IFE: Fatigability index of knee extensors; (measured in Newton with a dynamometer)
Measured: change from baseline physical condition at 12 weeks after the end of the treatment
measurement of the lean body mass condition
To describe lean body mass by impedancemeter
Measured: change from baseline physical condition at 12 weeks after the end of the treatment
measurement of the pulmonary function
Spirometry measures lung function, specifically the amount (volume) of air that can be inhaled and exhaled
Measured: change from baseline physical condition at 12 weeks after the end of the treatment
measurement of parameters reflecting the physical condition
To describe anxiety by Hospital Anxiety and Depression scale (14 items)
Measured: change from baseline physical condition at 12 weeks after the end of the treatment
measurement of parameters reflecting the physical condition
To describe physical activity level by by Global Physical Activity questionnaire
Measured: change from baseline physical condition at 12 weeks after the end of the treatment
measurement of parameters reflecting the physical condition
To describe physical performance index by Short Physical Performance Battery which is a group of measures that combines the results of the gait speed
Measured: change from baseline physical condition at 12 weeks after the end of the treatment
measurement of parameters reflecting the physical condition
To describe physical performance index by Short Physical Performance Battery which is a group of measures that combines the results of the chair stand
Measured: change from baseline physical condition at 12 weeks after the end of the treatment
measurement of parameters reflecting the physical condition
To describe physical performance index by Short Physical Performance Battery which is a group of measures that combines the results of the balance tests
Measured: change from baseline physical condition at 12 weeks after the end of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start17 Sep 2019
- Primary completion17 Sep 2020 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung Cancer MetastaticStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Paul Strauss
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roland SCHOTT, Md, Principal investigator, Centre Paul Strauss
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03956641
- Sponsor's protocol ID
- 2019-001
- Other IDs
- 2019-A00848-49
- Acronym
- PROTECT-01
- Status last verified
- Feb 2020
- First submitted
- 18 Apr 2019
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mallard J, Hucteau E, Schott R, Pivot X, Pagano AF, Hureau TJ. Tracking cancer-related fatigue during chemotherapy: Insights from a comparative cohort study of early breast cancer patients. Int J Cancer. 2025 Oct 15;157(8):1625-1636. doi: 10.1002/ijc.35508. Epub 2025 Jun 10.
PubMed 40492859Mallard J, Hucteau E, Schott R, Petit T, Demarchi M, Belletier C, Ben Abdelghani M, Carinato H, Chiappa P, Fischbach C, Kalish-Weindling M, Bousiniere 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.
PubMed 32903594
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of the Physical Condition in Treated Cancer Patients
- ClinicalTrials.gov ID
- NCT03956641
- Acronym / sponsor ID
- PROTECT-01 / 2019-001
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Centre Paul StraussUniversity, hospital or other
- Study start
- 17 Sep 2019 (actual)
- Primary completion
- 17 Sep 2020 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 21 May 2019 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental: observational cohort | Experimental | Other: Adaptated Physical ActivityEvaluation of the physical condition and the quality of life |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- Patient with psychiatric, neurologic or musculoskeletal disorders
- Pregnant or breastfeeding women
- Minor or protected adult
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 |
|---|---|---|
| Adaptated Physical ActivityEvaluation 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) | Other | experimental: observational cohort |
Primary outcome
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.
12 secondary outcomes
measurement of parameters reflecting the physical condition
Time frame: change from baseline physical condition at 12 weeks after the end of the treatment
measurement of parameters reflecting the physical condition
Time frame: change from baseline physical condition at 12 weeks after the end of the treatment
measurement of parameters reflecting the physical condition
Time frame: change from baseline physical condition at 12 weeks after the end of the treatment
measurement of parameters reflecting the physical condition
Time frame: change from baseline physical condition at 12 weeks after the end of the treatment
measurement of parameters reflecting the physical condition
Time frame: change from baseline physical condition at 12 weeks after the end of the treatment
measurement of the lean body mass condition
Time frame: change from baseline physical condition at 12 weeks after the end of the treatment
measurement of the pulmonary function
Time frame: change from baseline physical condition at 12 weeks after the end of the treatment
measurement of parameters reflecting the physical condition
Time frame: change from baseline physical condition at 12 weeks after the end of the treatment
measurement of parameters reflecting the physical condition
Time frame: change from baseline physical condition at 12 weeks after the end of the treatment
measurement of parameters reflecting the physical condition
Time frame: change from baseline physical condition at 12 weeks after the end of the treatment
measurement of parameters reflecting the physical condition
Time frame: change from baseline physical condition at 12 weeks after the end of the treatment
measurement of parameters reflecting the physical condition
Time frame: change from baseline physical condition at 12 weeks after the end of the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Derived from this study: PubMed 40492859Mallard J, Hucteau E, Schott R, Pivot X, Pagano AF, Hureau TJ. Tracking cancer-related fatigue during chemotherapy: Insights from a comparative cohort study of early breast cancer patients. Int J Cancer. 2025 Oct 15;157(8):1625-1636. doi: 10.1002/ijc.35508. Epub 2025 Jun 10.
- Derived from this study: PubMed 32903594Mallard J, Hucteau E, Schott R, Petit T, Demarchi M, Belletier C, Ben Abdelghani M, Carinato H, Chiappa P, Fischbach C, Kalish-Weindling M, Bousiniere 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.
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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.
Roland SCHOTT, Md principal investigator
Centre Paul Strauss
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptated Physical Activity in people with Non-small Cell Lung Cancer Metastatic and Breast Cancer Female, run by Centre Paul Strauss 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 8 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 11 Feb 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valerie SARTORI (+33 388 25 85 41, vsartori@strasbourg.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evolution of exercise tolerance (time frame: change from baseline exercise tolerance at 12 weeks after the end of the treatment). 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 NCT03956641, which also lists 2 linked publications.
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 11 Feb 2020.