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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03390816
Other study ID # 2017-A01397-46
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 2, 2017
Est. completion date June 27, 2019

Study information

Verified date April 2019
Source Société Francophone d'Onco-Gériatrie
Contact Elena PAILLAUD, PHD
Phone 01 49 81 30 74
Email elena.paillaud@aphp.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1886
Est. completion date June 27, 2019
Est. primary completion date December 27, 2018
Accepts healthy volunteers No
Gender All
Age group 70 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Nutritional assessment
Observational

Locations

Country Name City State
France Hôpital Henri Mondor Creteil

Sponsors (1)

Lead Sponsor Collaborator
Société Francophone d'Onco-Gériatrie

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary loss of weight 3 to 6 month-period preceding the cancer treatment
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