Impact on the Nutritional State and the Quality of Life
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|ClinicalTrials.gov Identifier: NCT01687335|
Recruitment Status : Completed
First Posted : September 18, 2012
Last Update Posted : March 10, 2023
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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.
|Condition or disease||Intervention/treatment|
|Cancer||Other: answering questionnare in differents time of the treatment|
|Study Type :||Observational|
|Actual Enrollment :||102 participants|
|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|
|Actual Study Start Date :||June 12, 2012|
|Actual Primary Completion Date :||March 31, 2016|
|Actual Study Completion Date :||March 31, 2016|
the patients benefiting from treatment by chemotherapy.
Other: answering questionnare in differents time of the treatment
- quality of life's improvement [ Time Frame: 3 YEARS ]
- improvement of treatment effectiveness, [ Time Frame: 3 YEARS ]
- improvement of their survival [ Time Frame: 3 YEARS ]
- improvement of the screening of the undernutrition [ Time Frame: 3 YEARS ]
- the answer to the treatment [ Time Frame: 3 years ]
- the estimation of the survival with regard to the nutritional state of the patient. [ Time Frame: 3 years ]
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|Ages Eligible for Study:||18 Years to 85 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01687335
|Assistance Publique Hopitaux de Marseille|
|Marseille, France, 13354|
|Study Director:||BERNARD BELAIGUES||Assistance Publique hôpitaux de Marseille|
|Responsible Party:||Assistance Publique Hopitaux De Marseille|
|Other Study ID Numbers:||
2011-11 ( Other Identifier: AP HM )
|First Posted:||September 18, 2012 Key Record Dates|
|Last Update Posted:||March 10, 2023|
|Last Verified:||March 2023|