NCT02806154

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2017

Longer than P75 for all trials

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 20, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

March 27, 2017

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2023

Completed
Last Updated

July 19, 2023

Status Verified

July 1, 2023

Enrollment Period

6 years

First QC Date

June 10, 2016

Last Update Submit

July 17, 2023

Conditions

Cancer

Keywords

CancerChemotherapy toxicityElderly patientsDEXAmuscle mass

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Functional autonomy impairment

    Up to 12 months

  • Functional physical performances impairment

    Up to 12 months

  • Quality of life impairment

    Up to 12 months

  • Early death

    Up to 12 months

Study Arms (1)

Elderly cancer patients

Elderly cancer patients treated with chemotherapy will have DEXA

Other: DEXA

Interventions

DEXAOTHER

The appendicular muscle mass measured by DEXA

Also known as: Dual Energy X-ray Absorptiometry
Elderly cancer patients

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Elderly cancer patients treated with chemotherapy

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Hôpital Sainte Marguerite

Marseille, France

Location

CH de Montauban

Montauban, France

Location

Institut du Cancer de Montpellier Val d'Aurelle

Montpellier, France

Location

CHU de Nantes

Nantes, France

Location

Hôpital de Cimiez, CHU Nice

Nice, France

Location

CH de Bigorre

Tarbes, France

Location

Hospital of Toulouse

Toulouse, 31059, France

Location

Institut Claudius Régaud

Toulouse, France

Location

Related 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.

    PMID: 31775667BACKGROUND

MeSH Terms

Conditions

Neoplasms

Interventions

Absorptiometry, Photon

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDensitometryPhotometryChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Laurent Balardy

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2016

First Posted

June 20, 2016

Study Start

March 27, 2017

Primary Completion

March 29, 2023

Study Completion

March 29, 2023

Last Updated

July 19, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(8)