Frailty and Body Composition in the Elderly Cancer Patients Treated With Chemotherapy
- Conditions
- Cancer
- Interventions
- Other: DEXA
- Registration Number
- NCT02806154
- Lead Sponsor
- University Hospital, Toulouse
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 144
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Elderly cancer patients DEXA Elderly cancer patients treated with chemotherapy will have DEXA
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
Early death Up to 12 months defined by a death occuring during the 3 first months from the initiation of the treatment
Trial Locations
- Locations (8)
Institut du Cancer de Montpellier Val d'Aurelle
🇫🇷Montpellier, France
Hôpital Sainte Marguerite
🇫🇷Marseille, France
CH de Montauban
🇫🇷Montauban, France
CHU de Nantes
🇫🇷Nantes, France
CH de Bigorre
🇫🇷Tarbes, France
Hospital of Toulouse
🇫🇷Toulouse, France
Institut Claudius Régaud
🇫🇷Toulouse, France
Hôpital de Cimiez, CHU Nice
🇫🇷Nice, France