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Completed

NCT Number: NCT02806154

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

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

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Key information

Conditions

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Sainte Marguerite, Marseille, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DEXA

Other

The appendicular muscle mass measured by DEXA

Other names: Dual Energy X-ray Absorptiometry

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

    Time frame: 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 outcomes

  1. Functional autonomy impairment

    Time frame: Up to 12 months

    defined as a loss of ≥ 0.5 point in Activities of Daily Living Scale.

  2. Functional physical performances impairment

    Time frame: Up to 12 months

    defined as a loss ≥ 1 point in the Short Physical Performance Battery

  3. Quality of life impairment

    Time frame: Up to 12 months

    defined as a loss ≥ 10 points in the EORTC quality of life questionnaire (QLQ) QLQ-C30 questionnaire

  4. Early death

    Time frame: Up to 12 months

    defined by a death occuring during the 3 first months from the initiation of the treatment

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Acronym: FRACTION

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Jun 20, 2016
Registry last updated
Jul 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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