Evolution of the Physical Condition in Treated Cancer Patients

Not Applicable

• Conditions: Non-small Cell Lung Cancer Metastatic; Breast Cancer Female; Colon Cancer
• Interventions: Other: Adaptated Physical Activity

• Registration Number: NCT03956641
• Lead Sponsor: Centre Paul Strauss

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 available

Study Timeline

• Study First Submitted: 2019-04-18
• Study First Submitted QC: 2019-05-16
• Study First Posted: 2019-05-21
• Study Start: 2019-09-17
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-10
• Last Update Posted: 2020-02-11
• Primary Completion: 2020-09-17
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
experimental: observational cohort	Adaptated Physical Activity	Evaluation of the physical condition and the quality of life

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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

Trial Locations

Locations (1)

Centre Paul Strauss; 🇫🇷 Strasbourg, France