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

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

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Other: DEXA

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.

• Study Type: Observational
• Enrollment (Actual): 144

Contacts and Locations

Study Locations

• France
  • Marseille, France
    • Hôpital Sainte Marguerite
  • Montauban, France
    • CH de Montauban
  • Montpellier, France
    • Institut du Cancer de Montpellier Val d'Aurelle
  • Nantes, France
    • CHU de Nantes
  • Nice, France
    • Hôpital de Cimiez, CHU Nice
  • Tarbes, France
    • CH de Bigorre
  • Toulouse, France
    • Institut Claudius Regaud
  • Toulouse, France, 31059
    • Hospital of Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Elderly cancer patients treated with chemotherapy

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Elderly cancer patients; Elderly cancer patients treated with chemotherapy will have DEXA	Other: DEXA; The appendicular muscle mass measured by DEXA; Other Names: Dual Energy X-ray Absorptiometry

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional autonomy impairment	defined as a loss of ≥ 0.5 point in Activities of Daily Living Scale.	Up to 12 months
Functional physical performances impairment	defined as a loss ≥ 1 point in the Short Physical Performance Battery	Up to 12 months
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
Early death	defined by a death occuring during the 3 first months from the initiation of the treatment	Up to 12 months

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Laurent Balardy, University Hospital, Toulouse

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2017
• Primary Completion (Actual): March 29, 2023
• Study Completion (Actual): March 29, 2023

Study Registration Dates

• First Submitted: June 10, 2016
• First Submitted That Met QC Criteria: June 17, 2016
• First Posted (Estimated): June 20, 2016

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 17, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Cancer; muscle mass; Elderly patients; DEXA; Chemotherapy toxicity
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: RC31/15/7831

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No