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Nutritional Intervention in Geriatric Oncology

Nutritional Intervention in Geriatric Oncology in Patients at Risk of Undernutrition

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00459589
Acronym
INOGAD
Enrollment
341
Registered
2007-04-12
Start date
2007-04-30
Completion date
2012-03-31
Last updated
2012-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, Cancer, Undernutrition

Keywords

Cancer, elderly, malnutrition, chemotherapy, survival, comprehensive geriatric assessment, morbidity

Brief summary

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.

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.

Interventions

BEHAVIORALnutritional 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

BEHAVIORALusual nutritional care

usual nutritional care

Sponsors

Ministry of Health, France
CollaboratorOTHER_GOV
Ligue contre le cancer, France
CollaboratorOTHER
University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Survival1 year

Secondary

MeasureTime frame
toxicity of chemotherapy (NTC CTCv3 scale)within 6 cycles of chemotherapy treatment,
quality of lifebefore and after chemotherapy treatment
biology (C-reactive protein [CRP], albumin, haemoglobin, creatinine clearance)before and after treatment
mood (GDS-15)before and after treatment
function: IADL, ADL, get up and go testbefore and after treatment
weightbefore and after treatment
Survival2 years
dietary intakesbefore and after treatment
hospitalisation frequencyduring treatment
opportunistic infection frequencyduring treatment
fall, breaks, pressure soreduring treatment
deathduring treatment and at 2 years
MNAbefore and after treatment

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026