We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Impact on the Nutritional State and the Quality of Life

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01687335
Recruitment Status : Completed
First Posted : September 18, 2012
Last Update Posted : March 10, 2023
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.


Condition or disease Intervention/treatment
Cancer Other: answering questionnare in differents time of the treatment

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 102 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
cancerous patients
the patients benefiting from treatment by chemotherapy.
 Other: answering questionnare in differents time of the treatment


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Study Population
cancerous patients benefiting from a treatment by chemotherapy
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Layout table for location information
France
Assistance Publique Hopitaux de Marseille
Marseille, France, 13354
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Layout table for investigator information
Study Director: BERNARD BELAIGUES Assistance Publique hôpitaux de Marseille
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT01687335    
Other Study ID Numbers: 2011-A00631-40
2011-11 ( Other Identifier: AP HM )
First Posted: September 18, 2012    Key Record Dates
Last Update Posted: March 10, 2023
Last Verified: March 2023
Keywords provided by Assistance Publique Hopitaux De Marseille:
chemotherapy