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Evolution of the Physical Condition in Treated Cancer Patients

Evolution of the Physical Condition in Treated Cancer Patients

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03956641
Acronym
PROTECT-01
Enrollment
300
Registered
2019-05-21
Start date
2019-09-17
Completion date
2021-06-01
Last updated
2020-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer Female, Colon Cancer, Non-small Cell Lung Cancer Metastatic

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.

Interventions

OTHERAdaptated 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)

Sponsors

Centre Paul Strauss
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
evolution of exercise tolerancechange from baseline exercise tolerance at 12 weeks after the end of the treatmentTo 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

MeasureTime frameDescription
measurement of parameters reflecting the physical conditionchange from baseline physical condition at 12 weeks after the end of the treatmentTo describe objective and felt fatigue by Fonctional assessment of chronic illness therapy-fatique (41 items scale)
measurement of the lean body mass conditionchange from baseline physical condition at 12 weeks after the end of the treatmentTo describe lean body mass by impedancemeter
measurement of the pulmonary functionchange from baseline physical condition at 12 weeks after the end of the treatmentSpirometry measures lung function, specifically the amount (volume) of air that can be inhaled and exhaled

Countries

France

Contacts

Primary ContactValerie SARTORI
vsartori@strasbourg.unicancer.fr+33 388 25 85 41
Backup ContactJoris MALLARD
jmallard@strasbourg.unicancer.fr+ 33 388 25 85 68

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026