Nutritional Intervention in Geriatric Oncology (INOGAD)

University Hospital of Bordeaux

Status

Completed

Conditions

Aging

Undernutrition

Cancer

Treatments

Behavioral: usual nutritional care

Behavioral: nutritional intervention with dietician plus usual nutritional care

Study type

Interventional

Funder types

Other

Identifiers

NCT00459589

2006/018

CHUBX 2006/11

Details and patient eligibility

About

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.

Full 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.

Enrollment

341 patients

Sex

All

Ages

70+ years old

Volunteers

No Healthy Volunteers

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.