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Frailty and Body Composition in the Elderly Cancer Patients Treated With Chemotherapy (FRACTION)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02806154
Recruitment Status : Recruiting
First Posted : June 20, 2016
Last Update Posted : November 9, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Study Description
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Brief Summary:
The investigators could hypothesize that age-related changes in body composition parameters play a role in the variable tolerance to chemotherapy in the elderly.

Condition or disease Intervention/treatment
Cancer Other: DEXA

Detailed Description:

However none of the studies relating body composition and chemotoxicity included elderly as a specific subpopulation. Furthermore in the majority of studies, body composition analyses are based on the estimation of muscle mass by CT scanner (axial L3 section). This method is to date not validated in the elderly cancer patients. Nevertheless some studies used Dual Energy X-ray Absorptiometry (DEXA), which is considered the gold standard in the assessment of body composition in older adults.

The investigators main hypothesis is that the appendicular muscle mass (I.e. muscle mass of the 4 limbs) operationalized as an index by dividing the muscle mass by squared height following Baumgartners' approach (Baumgartner, 1998) measured by DEXA (total of muscle mass of 4 limbs / height ²) represents a predictive factor of chemotoxicity in the elderly.

The finding that body composition is associated with poor tolerance of chemotherapy could lead to consider these parameters in the treatment decision of the elderly cancer patients and improve the current decision-making algorithms when treating older adults.

Study Design
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Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Frailty and Body Composition in the Elderly Cancer Patients Treated With Chemotherapy
Actual Study Start Date : March 27, 2017
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022
Groups and Cohorts
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Group/Cohort Intervention/treatment
Elderly cancer patients
Elderly cancer patients treated with chemotherapy will have DEXA
 Other: DEXA
The appendicular muscle mass measured by DEXA
Other Name: Dual Energy X-ray Absorptiometry


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Treatment-Related Adverse Events as Assessed by NCI-CTC v4.0 [ Time Frame: Up to 12 months ]
    Toxicity event defined by : first occurrence of grade 4 hematologic or grade 3-4 non hematologic toxicity as defined by the National Cancer Institute-Common Toxicity Criteria (NCI-CTC version 4) and/or disruption of chemotherapy because of inacceptable toxicity.


Secondary Outcome Measures :
  1. Functional autonomy impairment [ Time Frame: Up to 12 months ]
    defined as a loss of ≥ 0.5 point in Activities of Daily Living Scale.

  2. Functional physical performances impairment [ Time Frame: Up to 12 months ]
    defined as a loss ≥ 1 point in the Short Physical Performance Battery

  3. Quality of life impairment [ Time Frame: Up to 12 months ]
    defined as a loss ≥ 10 points in the EORTC QLQ-C30 questionnaire

  4. Early death [ Time Frame: Up to 12 months ]
    defined by a death occuring during the 3 first months from the initiation of the treatment


Eligibility Criteria
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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Elderly cancer patients treated with chemotherapy
Criteria

Inclusion Criteria:

  • Breast, prostate, bladder, colo-rectal, ovarian cancers, and lymphoma
  • Metastatic or locally advanced neoplasm
  • Initiation of first line chemotherapy
  • Performance status WHO 0-3
  • Capacity to give a written informed consent
  • Life expectancy > 3 mouths

Exclusion Criteria:

  • Concomitant targeted therapy
  • Concomitant targeted radiotherapy
  • Height > 196 cm, weight > 136 kg (DEXA not feasible)
  • Hemopathy excluding lymphoma
  • Cognitive impairment compromising the well proceeding and security of the study
  • Cognitive impairment compromising the obtaining of a written informed consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02806154


Contacts
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Contact: Laurent Balardy 0561776495 ext +33 balardy.l@chu-toulouse.fr

Locations
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France
Institut du Cancer de Montpellier Val d'Aurelle Recruiting
Montpellier, France
Contact: Laurence Cristol    0467612369 ext +33    laurence.cristol@montpellier.unicancer.fr   
CHU de Nantes Recruiting
Nantes, France
Contact: Laure De Decker, Dr       laure.dedecker@chu-nantes.fr   
Hôpital de Cimiez, CHU Nice Terminated
Nice, France
Hospital of Toulouse Recruiting
Toulouse, France, 31059
Contact: Laurent Balardy    0561776495 ext +33    balardy.l@chu-toulouse.fr   
Institut Claudius Régaud Recruiting
Toulouse, France
Contact: Loïc Mourey, MD    0531156056 ext +33      
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Laurent Balardy University Hospital, Toulouse
More Information
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Publications:

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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02806154    
Other Study ID Numbers: RC31/15/7831
First Posted: June 20, 2016    Key Record Dates
Last Update Posted: November 9, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
Cancer
Chemotherapy toxicity
Elderly patients
DEXA
muscle mass
Additional relevant MeSH terms:
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Frailty
Pathologic Processes