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
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
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-
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Bordeaux, France, 33076
- Institut Bergonié - 229 Cours de l'Argonne
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Pessac, France, 33604
- Pôle de Gériatrie - CHU Bordeaux-Hôpital Xavier Arnozan - Avenue du Haut-Lévèque
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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
|
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
|
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,
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within 6 cycles of chemotherapy treatment,
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|
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
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before and after treatment
|
|
hospitalisation frequency
Time Frame: during treatment
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during treatment
|
|
opportunistic infection frequency
Time Frame: during treatment
|
during treatment
|
|
fall, breaks, pressure sore
Time Frame: during treatment
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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
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.
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.