Impact on the Nutritional State and the Quality of Life

Cancer Clinical Trial

Official title:

Conformity With European Recommendations Concerning the Nutritional Care of the Cancerous Patients Benefiting From a Treatment by Chemotherapy Impact on the Nutritional State and the Quality of Life

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01687335
• Other study ID #: 2011-A00631-40
• Secondary ID: 2011-11
• Status: Completed
• Start date: June 12, 2012
• Est. completion date: March 31, 2016

Study information

• Verified date: March 2023
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The prevalence of malnutrition in cancerous patients varies between 50% and 80%. It is variable in function: the location and the extension of the tumor, of the general state , of age, of the socio-economic class and the pain. The health consequences of a malnutrition are very important: aggravation of the state of health, complications of treatment, hospitalization, alteration of the quality of life and decrease the survival, and the treatment response.

Nutrition being very important in patients, there are recommendations for the nutritional care of these patients, formulated by the European Society for Clinical Nutrition and Metabolism. The investigators do not know to what extent these recommendations are respected in practice and their influence on the nutritional status and the quality of life of patients.

The investigators therefore propose to assess the conformity of the nutritional care patients in clinical practice in relation to the European recommendations and in a second time to assess the influence of this compliance or non-compliance on the nutritional status clinical and biological of cancerous patients under chemotherapy, on their quality of life, on their response to treatment and on their survival.

The investigators will try to identify factors that may be linked to the non-compliance such as the characteristics of the cancer disease, socio-demographic characteristics of the subject and the factors related to the structure in which it is supported.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: March 31, 2016
• Est. primary completion date: March 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• 18-year-old subject in 85 years in the inclusion

• Subject presenting a cancerous pathology requiring a systematic treatment by exclusive chemotherapy for a minimal duration of three months with a plan of 3 cures of chemotherapy with an interval between the cures of 21 days

• Presenting subject one of these 4 cancerous pathologies: cancer of the aéro-digestive ways superiors, sarcomas, colorectal cancers, broncho-lung cancers

• Subject having the capacity of lira and to understand(include) French

• Subject having signed lit(enlightened) consent

• Subject taken care for its cancerous pathology in one of the partner services of the project

• Subject affiliated to the national insurance scheme

Exclusion Criteria:

• Subject having benefited from a major surgical operation in 4 weeks preceding the inclusion

• Subject having benefited from a radiotherapy in two weeks before the inclusion

• Subject minor(miner), pregnant woman, subject incapable to give its consent, subject under supervision(guardianship) - guardianship

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• answering questionnare in differents time of the treatment

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quality of life's improvement		3 YEARS
Primary	improvement of treatment effectiveness,		3 YEARS
Primary	improvement of their survival		3 YEARS
Secondary	improvement of the screening of the undernutrition		3 YEARS
Secondary	the answer to the treatment		3 years
Secondary	the estimation of the survival with regard to the nutritional state of the patient.		3 years