Impact on the Nutritional State and the Quality of Life

March 9, 2023 updated by: Assistance Publique Hopitaux De Marseille

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

102

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13354
        • Assistance Publique Hopitaux de Marseille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

cancerous patients benefiting from a treatment by chemotherapy

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
quality of life's improvement
Time Frame: 3 YEARS
3 YEARS
improvement of treatment effectiveness,
Time Frame: 3 YEARS
3 YEARS
improvement of their survival
Time Frame: 3 YEARS
3 YEARS

Secondary Outcome Measures

Outcome Measure
Time Frame
improvement of the screening of the undernutrition
Time Frame: 3 YEARS
3 YEARS
the answer to the treatment
Time Frame: 3 years
3 years
the estimation of the survival with regard to the nutritional state of the patient.
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2012

Primary Completion (Actual)

March 31, 2016

Study Completion (Actual)

March 31, 2016

Study Registration Dates

First Submitted

October 6, 2011

First Submitted That Met QC Criteria

September 17, 2012

First Posted (Estimate)

September 18, 2012

Study Record Updates

Last Update Posted (Estimate)

March 10, 2023

Last Update Submitted That Met QC Criteria

March 9, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2011-A00631-40
  • 2011-11 (Other Identifier: AP HM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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