Frailty and Body Composition in the Elderly Cancer Patients Treated With Chemotherapy (FRACTION)
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|ClinicalTrials.gov Identifier: NCT02806154|
Recruitment Status : Recruiting
First Posted : June 20, 2016
Last Update Posted : July 15, 2019
|Condition or disease||Intervention/treatment|
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 Type :||Observational|
|Estimated Enrollment :||160 participants|
|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 2020|
|Estimated Study Completion Date :||September 2020|
Elderly cancer patients
Elderly cancer patients treated with chemotherapy will have DEXA
The appendicular muscle mass measured by DEXA
Other Name: Dual Energy X-ray Absorptiometry
- 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.
- Functional autonomy impairment [ Time Frame: Up to 12 months ]defined as a loss of ≥ 0.5 point in Activities of Daily Living Scale.
- Functional physical performances impairment [ Time Frame: Up to 12 months ]defined as a loss ≥ 1 point in the Short Physical Performance Battery
- Quality of life impairment [ Time Frame: Up to 12 months ]defined as a loss ≥ 10 points in the EORTC QLQ-C30 questionnaire
- Early death [ Time Frame: Up to 12 months ]defined by a death occuring during the 3 first months from the initiation of the treatment
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
|Contact: Laurent Balardy||0561776495 ext +firstname.lastname@example.org|
|Institut du Cancer de Montpellier Val d'Aurelle||Recruiting|
|Contact: Laurence Cristol 0467612369 ext +33 email@example.com|
|CHU de Nantes||Recruiting|
|Contact: Laure De Decker, Dr firstname.lastname@example.org|
|Hôpital de Cimiez, CHU Nice||Terminated|
|Hospital of Toulouse||Recruiting|
|Toulouse, France, 31059|
|Contact: Laurent Balardy 0561776495 ext +33 email@example.com|
|Institut Claudius Régaud||Recruiting|
|Contact: Loïc Mourey, MD 0531156056 ext +33|
|Principal Investigator:||Laurent Balardy||University Hospital, Toulouse|