Cancer
Conditions
Keywords
Cancer, Chemotherapy toxicity, Elderly patients, DEXA, muscle mass
Brief summary
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
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.
Interventions
OTHERDEXA
The appendicular muscle mass measured by DEXA
Sponsors
University Hospital, Toulouse
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Related Adverse Events as Assessed by National Cancer Institute's - Common Toxicity Criteria (NCI-CTC) v4.0 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional autonomy impairment | Up to 12 months | defined as a loss of ≥ 0.5 point in Activities of Daily Living Scale. |
| Functional physical performances impairment | Up to 12 months | defined as a loss ≥ 1 point in the Short Physical Performance Battery |
| Quality of life impairment | Up to 12 months | defined as a loss ≥ 10 points in the EORTC quality of life questionnaire (QLQ) QLQ-C30 questionnaire |
| Early death | Up to 12 months | defined by a death occuring during the 3 first months from the initiation of the treatment |
Countries
France
Outcome results
None listed