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Nutritional Intervention in Geriatric Oncology in Patients at Risk of Undernutrition

70 Years
Not Enrolling
Cancer, Undernutrition, Aging

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Trial Information

Nutritional Intervention in Geriatric Oncology in Patients at Risk of Undernutrition

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.

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:


Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator


Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Bordeaux, France


France: Ministry of Health

Study ID:

CHUBX 2006/11



Start Date:

April 2007

Completion Date:

March 2012

Related Keywords:

  • Cancer
  • Undernutrition
  • Aging
  • Cancer
  • elderly
  • malnutrition
  • chemotherapy
  • survival
  • comprehensive geriatric assessment
  • morbidity
  • Food Habits
  • Malnutrition