Evolution of the Physical Condition in Treated Cancer Patients (PROTECT-01)

February 10, 2020 updated by: Centre Paul Strauss

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Strasbourg, France, 67200
        • Recruiting
        • Centre Paul Strauss
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental: observational cohort
Evaluation of the physical condition and the quality of life
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
change from baseline exercise tolerance at 12 weeks after the end of the treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measurement of parameters reflecting the physical condition
Time Frame: change from baseline physical condition at 12 weeks after the end of the treatment
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
measurement of parameters reflecting the physical condition
Time Frame: change from baseline physical condition at 12 weeks after the end of the treatment
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
measurement of parameters reflecting the physical condition
Time Frame: change from baseline physical condition at 12 weeks after the end of the treatment
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
measurement of parameters reflecting the physical condition
Time Frame: change from baseline physical condition at 12 weeks after the end of the treatment
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
measurement of parameters reflecting the physical condition
Time Frame: change from baseline physical condition at 12 weeks after the end of the treatment
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
measurement of the lean body mass condition
Time Frame: change from baseline physical condition at 12 weeks after the end of the treatment
To describe lean body mass by impedancemeter
change from baseline physical condition at 12 weeks after the end of the treatment
measurement of the pulmonary function
Time Frame: 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
change from baseline physical condition at 12 weeks after the end of the treatment
measurement of parameters reflecting the physical condition
Time Frame: change from baseline physical condition at 12 weeks after the end of the treatment
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
measurement of parameters reflecting the physical condition
Time Frame: change from baseline physical condition at 12 weeks after the end of the treatment
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
measurement of parameters reflecting the physical condition
Time Frame: 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 gait speed
change from baseline physical condition at 12 weeks after the end of the treatment
measurement of parameters reflecting the physical condition
Time Frame: 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 chair stand
change from baseline physical condition at 12 weeks after the end of the treatment
measurement of parameters reflecting the physical condition
Time Frame: 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
change from baseline physical condition at 12 weeks after the end of the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Paul Strauss

Investigators

  • Principal Investigator: Roland SCHOTT, Md, Centre Paul Strauss

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 17, 2019

Primary Completion (Anticipated)

September 17, 2020

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

April 18, 2019

First Submitted That Met QC Criteria

May 16, 2019

First Posted (Actual)

May 21, 2019

Study Record Updates

Last Update Posted (Actual)

February 11, 2020

Last Update Submitted That Met QC Criteria

February 10, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-001
  • 2019-A00848-49 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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