Nutritional Intervention in Geriatric Oncology (INOGAD)

June 19, 2012 updated by: University Hospital, Bordeaux

Nutritional Intervention in Geriatric Oncology in Patients at Risk of Undernutrition

Older patients with cancer are poorly treated or not treated at all. A previous study in the south west of France (364 patients) showed that patients receiving chemotherapy had short survival times which strongly depended on nutritional status. In this study, the researchers would like to evaluate if individual dietician follow-up at each cycle of chemotherapy increases survival of patients at risk of undernutrition.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Undernutrition in patients with cancer also called tumour cachexia concerns about 50% of this population during tumour progression. It's well established that loss of weight is poor prognosis factor in patients treated by chemotherapy in digestive cancers. Small number of studies assessing undernutrition, its management and consequences on prognosis were published. Previous study lead by our team in oncogeriatry in Aquitaine accrued 364 patients more than 70 years old and treated by chemotherapy for cancer. Median follow-up at 13 months for intermediary analysis about 155 first patients revealed at first geriatric evaluation, 28 pts (18.7%) were malnourished (MNA<17) and 72 pts (48.0%) at risk of malnutrition (MNA 17 to 23.5). At one year median follow-up major mortality was observed in 20 (71.4%) undernourished patients, 34 (47.2%) patients at risk of undernutrition and 13 (26.0%) patients without nutritional problem. According to consensus undernourished patients received nutritional support. Management of patients at risk of malnutrition is not clear. Our hypothesis is that nutritional support in patients at risk of undernutrition detected during geriatric evaluation could increase survival, safety, functional status and quality of life of patients. We construct an open multicentric two group randomized trial comparing usual nutritional management versus usual nutritional management plus nutritional intervention with dietician at each cycle of chemotherapy in 6 first cycles to maintain 30 kcal/kg/d and 1.2 protein/kg/d. Principal objective is to increase survival at 1 year with 10%. According to O'Brien and Fleming method we have to include 410 pts in each group, about 1640 pts will be evaluated by MNA test.

Study Type

Interventional

Enrollment (Actual)

341

Phase

  • Not Applicable

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
      • Bordeaux, France, 33076
        • Institut Bergonié - 229 Cours de l'Argonne
      • Pessac, France, 33604
        • Pôle de Gériatrie - CHU Bordeaux-Hôpital Xavier Arnozan - Avenue du Haut-Lévèque

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

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Over 70 years of age
  • Histologically proven cancer
  • Treatment by chemotherapy
  • Risk of undernutrition according to MNA score between 17 and 23.5
  • ECOG ≤ 3
  • Life expectancy > 12 weeks
  • Patient affiliated with the French social security regimen
  • Written informed consent

Exclusion Criteria:

  • MNA score under 17 or over 23.5
  • Geographic, psychological, or social conditions potentially hampering compliance with the study protocol
  • Symptomatic central nervous system (CNS) metastases
  • Chemotherapy treatments not published as standard protocols
  • Treatment that does not allow geriatric evaluation and dietician follow-up.

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 2
Behavioral: usual nutritional care
usual nutritional care
Experimental: 1
nutritional intervention with dietician at each cycle of chemotherapy in 6 first cycles to maintain 30 kcal/kg/d and 1.2 protein/kg/d
Behavioral: nutritional intervention with dietician plus usual nutritional care
nutritional intervention with dietician at each cycle of chemotherapy in 6 first cycles to maintain 30 kcal/kg/d and 1.2 protein/kg/d

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Survival
Time Frame: 2 years
2 years
toxicity of chemotherapy (NTC CTCv3 scale)
Time Frame: within 6 cycles of chemotherapy treatment,
within 6 cycles of chemotherapy treatment,
quality of life
Time Frame: before and after chemotherapy treatment
before and after chemotherapy treatment
biology (C-reactive protein [CRP], albumin, haemoglobin, creatinine clearance)
Time Frame: before and after treatment
before and after treatment
mood (GDS-15)
Time Frame: before and after treatment
before and after treatment
function: IADL, ADL, get up and go test
Time Frame: before and after treatment
before and after treatment
weight
Time Frame: before and after treatment
before and after treatment
MNA
Time Frame: before and after treatment
before and after treatment
dietary intakes
Time Frame: before and after treatment
before and after treatment
hospitalisation frequency
Time Frame: during treatment
during treatment
opportunistic infection frequency
Time Frame: during treatment
during treatment
fall, breaks, pressure sore
Time Frame: during treatment
during treatment
death
Time Frame: during treatment and at 2 years
during treatment and at 2 years

Collaborators and Investigators

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

Sponsor

University Hospital, Bordeaux

Collaborators

Ministry of Health, France
Ligue contre le cancer, France

Investigators

  • Principal Investigator: Isabelle BOURDEL MARCHASSON, Pr., University Hospital, Bordeaux, France

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

April 1, 2007

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

April 11, 2007

First Submitted That Met QC Criteria

April 11, 2007

First Posted (Estimate)

April 12, 2007

Study Record Updates

Last Update Posted (Estimate)

June 20, 2012

Last Update Submitted That Met QC Criteria

June 19, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2006/11
  • 2006/018

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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