Clinical trial NCT02806154: Frailty and Body Composition in the Elderly Cancer Patients Treated With Chemotherapy
Official title: Frailty and Body Composition in the Elderly Cancer Patients Treated With Chemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: Cancer
Chemotherapy toxicity
Elderly patients
DEXA
muscle mass
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2016-06-20
Enrollment: 144
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly cancer patients treated with chemotherapy

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Treatment-Related Adverse Events as Assessed by National Cancer Institute's - Common Toxicity Criteria (NCI-CTC) v4.0
timeFrame: Up to 12 months
Secondary outcomes:
measure: Functional autonomy impairment
timeFrame: Up to 12 months
measure: Functional physical performances impairment
timeFrame: Up to 12 months
measure: Quality of life impairment
timeFrame: Up to 12 months
measure: Early death
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hôpital Sainte Marguerite
city: Montauban
country: France
facility: CH de Montauban
city: Montpellier
country: France
facility: Institut du Cancer de Montpellier Val d'Aurelle
city: Nantes
country: France
facility: CHU de Nantes
city: Nice
country: France
facility: Hôpital de Cimiez, CHU Nice
city: Tarbes
country: France
facility: CH de Bigorre
city: Toulouse
country: France
facility: Hospital of Toulouse
city: Toulouse
country: France
facility: Institut Claudius Régaud
Study officials:
affiliation: University Hospital, Toulouse
name: Laurent Balardy
role: PRINCIPAL_INVESTIGATOR
References:
citation: Steinmeyer Z, Gerard S, Filleron T, Lozano S, Brechemier D, Abellan Van Kan G, Mourey L, Cristol-Dalstein L, De Decker L, Rolland Y, Balardy L. Low lean mass and chemotherapy toxicity risk in the elderly: the Fraction study protocol. BMC Cancer. 2019 Nov 27;19(1):1153. doi: 10.1186/s12885-019-6377-7.