MalnutritionNutriAgeCancerNCT03390816
Nutritional Status Assessment in the Elderly Suffering From Cancer : a National Cross-UCOG Survey
An observational study of Malnutrition and Cancer, run by Société Francophone d'Onco-Gériatrie at 1 site in France.
Trial summary
Protein-energy malnutrition (PEM) is a frequent condition in patients suffering from cancer, especially the elderly. According to some studies, this malnutrition has important consequences in this population, by increasing the risk of treatment toxicities, premature interruption of chemotherapy, mortality and risks of… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Malnutrition, Cancer, Elderly
- What is being tested?
- Nutritional assessment
- How many people
- 1,886 participants
- Where
- 1 siteFrance
- Study dates
- 2 Nov 2017to 27 Jun 2019
- 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 people, who are more than 70 years old, suffering from cancer, waiting for a treatment decision and taken care of in a hospital
Who may be able to join
- Over 70 years of age
- Suffering from cancer
- Waiting for a treatment decision (whatever it is)
- Hospitalized in a hospital or come to consult in a hospital during the period of inclusion (2 periods of 6 weeks for two consecutive years)
- Affiliated to a social security system
Who cannot join
- Patient unable to receive information regarding the study and/or provide its non objection regarding the use of its data
- Patient under tutorship or curatorship, deprived of freedom or placed under judicial protection
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital Henri Mondor
Créteil, 94000
Elena PAILLAUD, PHD, 01 49 81 30 74 ext. +33, elena.paillaud@aphp.fr
About this study
Official title: Nutritional Status Assessment in the Elderly Suffering From Cancer (NutriAgeCancer) : a National Cross-UCOG Survey
Protein-energy malnutrition (PEM) is a frequent condition in patients suffering from cancer, especially the elderly. According to some studies, this malnutrition has important consequences in this population, by increasing the risk of treatment toxicities, premature interruption of chemotherapy, mortality and risks of complications. Identifying cases of malnutrition is an objective pursued by the National Nutrition and Health Programme and an important task of the "Unités de Coordination en Oncogériatrie".
The main goal of this study is to assess the loss of weight over the 6 month-period preceding the cancer treatment, regardless of kind (chemotherapy, targeted therapy, hormone therapy, immunotherapy, radiation therapy, surgery, comfort care), in the elderly suffering from cancer.
- Conditions
- Malnutrition, Cancer, Elderly
- Being tested
- Nutritional assessment
- Keywords
- malnutrition, cancer, elderly
- Medical subject headings
- Malnutrition, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional assessmentOther
Observational
| Study group | Role | What they receive |
|---|---|---|
| Transversal | Elderly people, who are more than 70 years old, suffering from cancer, waiting for a treatment decision and taken care of in a hospital Receives: Other: Nutritional assessment | |
| Longitudinal | Elderly people, who are more than 70 years old, suffering from cancer, waiting for a treatment decision and taken care of in a hospital Forward-looking follow-up of 6 months of a sub-sample during the first year Receives: Other: Nutritional assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
loss of weight
Measured: 3 to 6 month-period preceding the cancer treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2018
- Study start2 Nov 2017
- Primary completion27 Dec 2018
- Study completion27 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- 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
- 1,886 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Société Francophone d'Onco-Gériatrie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elena PAILLAUD, PHD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03390816
- Sponsor's protocol ID
- 2017-A01397-46
- Acronym
- NutriAgeCancer
- Status last verified
- Apr 2019
- First submitted
- 28 Dec 2017
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Status Assessment in the Elderly Suffering From Cancer (NutriAgeCancer) : a National Cross-UCOG Survey
- ClinicalTrials.gov ID
- NCT03390816
- Acronym / sponsor ID
- NutriAgeCancer / 2017-A01397-46
- Conditions
- Malnutrition, Cancer, Elderly
- Keywords
- malnutrition, cancer, elderly
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,886 participants (estimated)
- Lead sponsor
- Société Francophone d'Onco-GériatrieUniversity, hospital or other
- Study start
- 2 Nov 2017 (actual)
- Primary completion
- 27 Dec 2018 (actual)
- Study completion
- 27 Jun 2019 (estimated)
- First posted
- 4 Jan 2018 (actual)
- 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.
Protein-energy malnutrition (PEM) is a frequent condition in patients suffering from cancer, especially the elderly. According to some studies, this malnutrition has important consequences in this population, by increasing the risk of treatment toxicities, premature interruption of chemotherapy, mortality and risks of complications. Identifying cases of malnutrition is an objective pursued by the National Nutrition and Health Programme and an important task of the "Unités de Coordination en Oncogériatrie".
The main goal of this study is to assess the loss of weight over the 6 month-period preceding the cancer treatment, regardless of kind (chemotherapy, targeted therapy, hormone therapy, immunotherapy, radiation therapy, surgery, comfort care), in the elderly suffering from cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transversal | – | Other: Nutritional assessmentElderly people, who are more than 70 years old, suffering from cancer, waiting for a treatment decision and taken care of in a hospital |
| Longitudinal | – | Other: Nutritional assessmentElderly people, who are more than 70 years old, suffering from cancer, waiting for a treatment decision and taken care of in a hospital Forward-looking follow-up of 6 months of a sub-sample during the first year |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly people, who are more than 70 years old, suffering from cancer, waiting for a treatment decision and taken care of in a hospital
Key inclusion criteria (5 listed)
- Over 70 years of age
- Suffering from cancer
- Waiting for a treatment decision (whatever it is)
- Hospitalized in a hospital or come to consult in a hospital during the period of inclusion (2 periods of 6 weeks for two consecutive years)
- Affiliated to a social security system
Key exclusion criteria (2 listed)
- Patient unable to receive information regarding the study and/or provide its non objection regarding the use of its data
- Patient under tutorship or curatorship, deprived of freedom or placed under judicial protection
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 |
|---|---|---|
| Nutritional assessmentObservational | Other | Longitudinal, Transversal |
Primary outcome
loss of weight
Time frame: 3 to 6 month-period preceding the cancer treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
- 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.
Elena PAILLAUD, PHD principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition and Cancer, run by Société Francophone d'Onco-Gériatrie at 1 site 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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elena PAILLAUD, PHD (01 49 81 30 74 ext. +33, elena.paillaud@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
loss of weight (time frame: 3 to 6 month-period preceding the cancer treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2019.