CancerFRACTIONNCT02806154
Frailty and Body Composition in the Elderly Cancer Patients Treated With Chemotherapy
An observational study of Cancer, run by University Hospital, Toulouse at 8 sites in France.
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- DEXA
- How many people
- 144 participants
- Where
- 8 sitesFrance
- Study dates
- 27 Mar 2017to 29 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly cancer patients treated with chemotherapy
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Hôpital Sainte Marguerite
Marseille
CH de Montauban
Montauban
Institut du Cancer de Montpellier Val d'Aurelle
Montpellier
CHU de Nantes
Nantes
Hôpital de Cimiez, CHU Nice
Nice
CH de Bigorre
Tarbes
Hospital of Toulouse
Toulouse, 31059
Institut Claudius Régaud
Toulouse
About this study
The investigators could hypothesize that age-related changes in body composition parameters play a role in the variable tolerance to chemotherapy in the elderly.
Read the 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.
- Conditions
- Cancer
- Being tested
- DEXA
- Keywords
- Cancer, Chemotherapy toxicity, Elderly patients, DEXA, muscle mass
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEXAOther
Also called Dual Energy X-ray Absorptiometry
The appendicular muscle mass measured by DEXA
| Study group | Role | What they receive |
|---|---|---|
| Elderly cancer patients | Elderly cancer patients treated with chemotherapy will have DEXA Receives: Other: DEXA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 months
Secondary outcomes (4)
Functional autonomy impairment
defined as a loss of ≥ 0.5 point in Activities of Daily Living Scale.
Measured: Up to 12 months
Functional physical performances impairment
defined as a loss ≥ 1 point in the Short Physical Performance Battery
Measured: 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
Measured: Up to 12 months
Early death
defined by a death occuring during the 3 first months from the initiation of the treatment
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study start27 Mar 2017
- Primary completion29 Mar 2023
- Study completion29 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent Balardy, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02806154
- Sponsor's protocol ID
- RC31/15/7831
- Acronym
- FRACTION
- Status last verified
- Jul 2023
- First submitted
- 10 Jun 2016
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31775667
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frailty and Body Composition in the Elderly Cancer Patients Treated With Chemotherapy
- ClinicalTrials.gov ID
- NCT02806154
- Acronym / sponsor ID
- FRACTION / RC31/15/7831
- Conditions
- Cancer
- Keywords
- Cancer, Chemotherapy toxicity, Elderly patients, DEXA, muscle mass
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 27 Mar 2017 (actual)
- Primary completion
- 29 Mar 2023 (actual)
- Study completion
- 29 Mar 2023 (actual)
- First posted
- 20 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators could hypothesize that age-related changes in body composition parameters play a role in the variable tolerance to chemotherapy in the elderly.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly cancer patients | – | Other: DEXAElderly cancer patients treated with chemotherapy will have DEXA |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly cancer patients treated with chemotherapy
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DEXAAlso: Dual Energy X-ray AbsorptiometryThe appendicular muscle mass measured by DEXA | Other | Elderly cancer patients |
Primary outcome
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.
4 secondary outcomes
Functional autonomy impairment
Time frame: Up to 12 months
Functional physical performances impairment
Time frame: Up to 12 months
Quality of life impairment
Time frame: Up to 12 months
Early death
Time frame: Up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
- Background: PubMed 31775667Steinmeyer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent Balardy principal investigator
University Hospital, Toulouse
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by University Hospital, Toulouse at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02806154, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2023.