- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03390816
Nutritional Status Assessment in the Elderly Suffering From Cancer : a National Cross-UCOG Survey (NutriAgeCancer)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
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Creteil, France, 94000
- Recruiting
- Hôpital Henri Mondor
-
Contact:
- Elena PAILLAUD, PHD
- Phone Number: +33 01 49 81 30 74
- Email: elena.paillaud@aphp.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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
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Observational
|
|
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
|
Observational
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
loss of weight
Time Frame: 3 to 6 month-period preceding the cancer treatment
|
3 to 6 month-period preceding the cancer treatment
|
Collaborators and Investigators
Investigators
- Principal Investigator: Elena PAILLAUD, PHD, APHP
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-A01397-46
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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