Nutritional Status Assessment in the Elderly Suffering From Cancer : a National Cross-UCOG Survey (NutriAgeCancer)

April 2, 2019 updated by: Société Francophone d'Onco-Gériatrie

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

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1886

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Creteil, France, 94000
        • Recruiting
        • Hopital Henri Mondor
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Other: Nutritional assessment
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
Other: Nutritional assessment
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

This is where you will find people and organizations involved with this study.

Sponsor

Société Francophone d'Onco-Gériatrie

Investigators

  • Principal Investigator: Elena PAILLAUD, PHD, APHP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2017

Primary Completion (Actual)

December 27, 2018

Study Completion (Anticipated)

June 27, 2019

Study Registration Dates

First Submitted

December 28, 2017

First Submitted That Met QC Criteria

December 28, 2017

First Posted (Actual)

January 4, 2018

Study Record Updates

Last Update Posted (Actual)

April 4, 2019

Last Update Submitted That Met QC Criteria

April 2, 2019

Last Verified

April 1, 2019

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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