Evolution of the Physical Condition in Treated Cancer Patients

Colon Cancer Clinical Trial

— PROTECT-01  

Official title:

Evolution of the Physical Condition in Treated Cancer Patients

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
• 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
• 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

Related Conditions & MeSH terms

• Breast Cancer Female
• Carcinoma, Non-Small-Cell Lung
• Colon Cancer
• Colonic Neoplasms
• Non-small Cell Lung Cancer Metastatic

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