NCT03390816

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,886

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 4, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2019

Completed
Last Updated

April 4, 2019

Status Verified

April 1, 2019

Enrollment Period

1.2 years

First QC Date

December 28, 2017

Last Update Submit

April 2, 2019

Conditions

Keywords

malnutritioncancerelderly

Outcome Measures

Primary Outcomes (1)

  • loss of weight

    3 to 6 month-period preceding the cancer treatment

Study Arms (2)

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

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

Interventions

Observational

LongitudinalTransversal

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Over 70 years of age
  • Suffering from cancer
  • Waiting for a treatment decision (whatever it is)
  • Affiliated to a social security system

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Henri Mondor

Créteil, 94000, France

RECRUITING

MeSH Terms

Conditions

MalnutritionNeoplasms

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Elena PAILLAUD, PHD

    APHP

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elena PAILLAUD, PHD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2017

First Posted

January 4, 2018

Study Start

November 2, 2017

Primary Completion

December 27, 2018

Study Completion

June 27, 2019

Last Updated

April 4, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations