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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03956641
Other study ID # 2019-001
Secondary ID 2019-A00848-49
Status Recruiting
Phase N/A
First received
Last updated
Start date September 17, 2019
Est. completion date June 1, 2021

Study information

Verified date February 2020
Source Centre Paul Strauss
Contact Valerie SARTORI
Phone +33 388 25 85 41
Email vsartori@strasbourg.unicancer.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date June 1, 2021
Est. primary completion date September 17, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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)

Locations

Country Name City State
France Centre Paul Strauss Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
Centre Paul Strauss

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. change from baseline exercise tolerance at 12 weeks after the end of the treatment
Secondary measurement of parameters reflecting the physical condition To describe objective and felt fatigue by Fonctional assessment of chronic illness therapy-fatique (41 items scale) change from baseline physical condition at 12 weeks after the end of the treatment
Secondary measurement of parameters reflecting the physical condition To describe muscular strenght by FPmax: Maximal strenght of finger flexors; (measured in Newton with a dynamometer) change from baseline physical condition at 12 weeks after the end of the treatment
Secondary measurement of parameters reflecting the physical condition To describe muscular strenght by IFP: Fatigability indexof finger flexors; (measured in Newton with a dynamometer) change from baseline physical condition at 12 weeks after the end of the treatment
Secondary 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) change from baseline physical condition at 12 weeks after the end of the treatment
Secondary measurement of parameters reflecting the physical condition To describe muscular strenght by IFE: Fatigability index of knee extensors; (measured in Newton with a dynamometer) change from baseline physical condition at 12 weeks after the end of the treatment
Secondary measurement of the lean body mass condition To describe lean body mass by impedancemeter change from baseline physical condition at 12 weeks after the end of the treatment
Secondary measurement of the pulmonary function Spirometry measures lung function, specifically the amount (volume) of air that can be inhaled and exhaled change from baseline physical condition at 12 weeks after the end of the treatment
Secondary measurement of parameters reflecting the physical condition To describe anxiety by Hospital Anxiety and Depression scale (14 items) change from baseline physical condition at 12 weeks after the end of the treatment
Secondary measurement of parameters reflecting the physical condition To describe physical activity level by by Global Physical Activity questionnaire change from baseline physical condition at 12 weeks after the end of the treatment
Secondary 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 change from baseline physical condition at 12 weeks after the end of the treatment
Secondary 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 change from baseline physical condition at 12 weeks after the end of the treatment
Secondary 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 change from baseline physical condition at 12 weeks after the end of the treatment
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