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The investigators could hypothesize that age-related changes in body composition parameters play a role in the variable tolerance to chemotherapy in the elderly.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elderly cancer patients | Elderly cancer patients treated with chemotherapy will have DEXA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DEXA | Other | The appendicular muscle mass measured by DEXA |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Related Adverse Events as Assessed by National Cancer Institute's - Common Toxicity Criteria (NCI-CTC) v4.0 | 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. | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Functional autonomy impairment | defined as a loss of ≥ 0.5 point in Activities of Daily Living Scale. | Up to 12 months |
| Functional physical performances impairment | defined as a loss ≥ 1 point in the Short Physical Performance Battery |
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Inclusion Criteria:
Exclusion Criteria:
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Elderly cancer patients treated with chemotherapy
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| Name | Affiliation | Role |
|---|---|---|
| Laurent Balardy | University Hospital, Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Sainte Marguerite | Marseille | France | ||||
| CH de Montauban |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31775667 | Background | Steinmeyer Z, Gerard S, Filleron T, Lozano S, Brechemier D, Abellan Van Kan G, Mourey L, Cristol-Dalstein L, De Decker L, Rolland Y, Balardy L. Low lean mass and chemotherapy toxicity risk in the elderly: the Fraction study protocol. BMC Cancer. 2019 Nov 27;19(1):1153. doi: 10.1186/s12885-019-6377-7. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D015502 | Absorptiometry, Photon |
| ID | Term |
|---|---|
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Up to 12 months |
| Quality of life impairment | defined as a loss ≥ 10 points in the EORTC quality of life questionnaire (QLQ) QLQ-C30 questionnaire | Up to 12 months |
| Early death | defined by a death occuring during the 3 first months from the initiation of the treatment | Up to 12 months |
| Montauban |
| France |
| Institut du Cancer de Montpellier Val d'Aurelle | Montpellier | France |
| CHU de Nantes | Nantes | France |
| Hôpital de Cimiez, CHU Nice | Nice | France |
| CH de Bigorre | Tarbes | France |
| Hospital of Toulouse | Toulouse | 31059 | France |
| Institut Claudius Régaud | Toulouse | France |
| D003720 |
| Densitometry |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |