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

Toulouse University Hospital

Status: Completed

Conditions: Cancer

Treatments: Other: DEXA

Study type: Observational

Funder types: Other

Identifiers

NCT02806154

RC31/15/7831

Details and patient eligibility

About

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

Full 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.

Enrollment: 144 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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

Trial design

144 participants in 1 patient group

Elderly cancer patients

Description:

Elderly cancer patients treated with chemotherapy will have DEXA

Treatment:

Other: DEXA