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

Cancer Clinical Trial

— FRACTION  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02806154
• Other study ID #: RC31/15/7831
• Status: Completed
• Start date: March 27, 2017
• Est. completion date: March 29, 2023

Study information

• Verified date: July 2023
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: March 29, 2023
• Est. primary completion date: March 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Frailty

Intervention

Other:
• DEXA
The appendicular muscle mass measured by DEXA

Locations

Country	Name	City	State
France	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	Hôpital de Cimiez, CHU Nice	Nice
France	CH de Bigorre	Tarbes
France	Hospital of Toulouse	Toulouse
France	Institut Claudius Régaud	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 12 months
Secondary	Functional autonomy impairment	defined as a loss of = 0.5 point in Activities of Daily Living Scale.	Up to 12 months
Secondary	Functional physical performances impairment	defined as a loss = 1 point in the Short Physical Performance Battery	Up to 12 months
Secondary	Quality of life impairment	defined as a loss = 10 points in the EORTC quality of life questionnaire (QLQ) QLQ-C30 questionnaire	Up to 12 months
Secondary	Early death	defined by a death occuring during the 3 first months from the initiation of the treatment	Up to 12 months