Clinical trial NCT03956641: Evolution of the Physical Condition in Treated Cancer Patients
Official title: Evolution of the Physical Condition in Treated Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-small Cell Lung Cancer Metastatic
Breast Cancer Female
Colon Cancer
Lead sponsor: Centre Paul Strauss
Sponsor class: OTHER
First posted: 2019-05-21
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: evolution of exercise tolerance
timeFrame: change from baseline exercise tolerance at 12 weeks after the end of the treatment
Secondary outcomes:
measure: measurement of parameters reflecting the physical condition
timeFrame: change from baseline physical condition at 12 weeks after the end of the treatment
measure: measurement of parameters reflecting the physical condition
timeFrame: change from baseline physical condition at 12 weeks after the end of the treatment
measure: measurement of parameters reflecting the physical condition
timeFrame: change from baseline physical condition at 12 weeks after the end of the treatment
measure: measurement of parameters reflecting the physical condition
timeFrame: change from baseline physical condition at 12 weeks after the end of the treatment
measure: measurement of parameters reflecting the physical condition
timeFrame: change from baseline physical condition at 12 weeks after the end of the treatment
measure: measurement of the lean body mass condition
timeFrame: change from baseline physical condition at 12 weeks after the end of the treatment
measure: measurement of the pulmonary function
timeFrame: change from baseline physical condition at 12 weeks after the end of the treatment
measure: measurement of parameters reflecting the physical condition
timeFrame: change from baseline physical condition at 12 weeks after the end of the treatment
measure: measurement of parameters reflecting the physical condition
timeFrame: change from baseline physical condition at 12 weeks after the end of the treatment
measure: measurement of parameters reflecting the physical condition
timeFrame: change from baseline physical condition at 12 weeks after the end of the treatment
measure: measurement of parameters reflecting the physical condition
timeFrame: change from baseline physical condition at 12 weeks after the end of the treatment
measure: measurement of parameters reflecting the physical condition
timeFrame: change from baseline physical condition at 12 weeks after the end of the treatment
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Centre Paul Strauss
Study officials:
affiliation: Centre Paul Strauss
name: Roland SCHOTT, Md
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mallard 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.