Clinical trial · Observational
Frailty and Body Composition in the Elderly Cancer Patients Treated With Chemotherapy
NCT02806154CI-TRIAL-00068104FRACTIONcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The investigators could hypothesize that age-related changes in body composition parameters play a role in the variable tolerance to chemotherapy in the elderly.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DEXA | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Elderly cancer patients
- description
- Elderly cancer patients treated with chemotherapy will have DEXA
- interventionNames
- Other: DEXA
Primary outcomes (1)
- 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
- description
- 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 (4)
- measure
- Functional autonomy impairment
- timeFrame
- Up to 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDSteinmeyer 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 31775667