NCT01687335

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2011

Completed
8 months until next milestone

Study Start

First participant enrolled

June 12, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 18, 2012

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2016

Completed
Last Updated

March 10, 2023

Status Verified

March 1, 2023

Enrollment Period

3.8 years

First QC Date

October 6, 2011

Last Update Submit

March 9, 2023

Conditions

Cancer

Keywords

chemotherapy

Outcome Measures

Primary Outcomes (3)

  • quality of life's improvement

    3 YEARS

  • improvement of treatment effectiveness,

    3 YEARS

  • improvement of their survival

    3 YEARS

Secondary Outcomes (3)

  • improvement of the screening of the undernutrition

    3 YEARS

  • the answer to the treatment

    3 years

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

    3 years

Study Arms (1)

cancerous patients

the patients benefiting from treatment by chemotherapy.

Other: answering questionnare in differents time of the treatment

Interventions

answering questionnare in differents time of the treatmentOTHER
cancerous patients

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

cancerous patients benefiting from a treatment by chemotherapy

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

Related Publications (1)

  • Salas S, Mercier S, Moheng B, Olivet S, Garcia ME, Hamon S, Sibertin-Blanc C, Duffaud F, Auquier P, Baumstarck K. Nutritional status and quality of life of cancer patients needing exclusive chemotherapy: a longitudinal study. Health Qual Life Outcomes. 2017 Apr 27;15(1):85. doi: 10.1186/s12955-017-0660-6.

    PMID: 28449674DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

  • BERNARD BELAIGUES

    Assistance Publique hôpitaux de Marseille

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2011

First Posted

September 18, 2012

Study Start

June 12, 2012

Primary Completion

March 31, 2016

Study Completion

March 31, 2016

Last Updated

March 10, 2023

Record last verified: 2023-03

Locations

FR(1)