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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Frailty and Body Composition in the Elderly Cancer Patients Treated With Chemotherapy

Conditions
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Cancer

Intervention / Treatment
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* Other: DEXA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Breast, prostate, bladder, colo-rectal, ovarian cancers, and lymphoma Metastatic or locally advanced neoplasm Initiation of first line chemotherapy Performance status World Health Organization (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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Elderly cancer patients<br>Elderly cancer patients treated with chemotherapy will have DEXA | Other: DEXA<br>* The appendicular muscle mass measured by DEXA<br>* Other names: Dual Energy X-ray Absorptiometry;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Chemotherapy toxicity, Elderly patients, DEXA, muscle mass