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Completed

NCT Number: NCT01687335

Impact on the Nutritional State and the Quality of Life

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

answering questionnare in differents time of the treatment

Other

Primary outcomes

  1. quality of life's improvement

    Time frame: 3 YEARS

  2. improvement of treatment effectiveness,

    Time frame: 3 YEARS

  3. improvement of their survival

    Time frame: 3 YEARS

Secondary outcomes

  1. improvement of the screening of the undernutrition

    Time frame: 3 YEARS

  2. the answer to the treatment

    Time frame: 3 years

  3. the estimation of the survival with regard to the nutritional state of the patient.

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Sep 18, 2012
Registry last updated
Mar 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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