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Clinical Trials/NCT03956641
NCT03956641
Unknown
Not Applicable

Evolution of the Physical Condition in Treated Cancer Patients

Centre Paul Strauss1 site in 1 country300 target enrollmentSeptember 17, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Non-small Cell Lung Cancer Metastatic
Sponsor
Centre Paul Strauss
Enrollment
300
Locations
1
Primary Endpoint
evolution of exercise tolerance
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 17, 2019
End Date
June 1, 2021
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Centre Paul Strauss
Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

  • measurement of parameters reflecting the physical condition(change from baseline physical condition at 12 weeks after the end of the treatment)
  • measurement of the lean body mass condition(change from baseline physical condition at 12 weeks after the end of the treatment)
  • measurement of the pulmonary function(change from baseline physical condition at 12 weeks after the end of the treatment)

Study Sites (1)

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