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

University Hospital, Toulouse144 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

144

Conditions

Cancer

Interventions

DEXAOTHER

The appendicular muscle mass measured by DEXA

Eligibility

Sex: ALLMin age: 70 Years

Medical Language ↔ Plain English

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

Locations (8)

Hôpital Sainte Marguerite

Marseille, France

CH de Montauban

Montauban, France

Institut du Cancer de Montpellier Val d'Aurelle

Montpellier, France

CHU de Nantes

Nantes, France

Outcomes

Primary Outcomes

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.

Time frame: Up to 12 months

Secondary Outcomes

Functional autonomy impairment

defined as a loss of ≥ 0.5 point in Activities of Daily Living Scale.

Time frame: Up to 12 months

Functional physical performances impairment

defined as a loss ≥ 1 point in the Short Physical Performance Battery

Time frame: 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

Time frame: Up to 12 months

Early death

defined by a death occuring during the 3 first months from the initiation of the treatment

Time frame: Up to 12 months

Data from ClinicalTrials.gov

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