Clinical trial NCT00459589: Nutritional Intervention in Geriatric Oncology
Official title: Nutritional Intervention in Geriatric Oncology in Patients at Risk of Undernutrition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Undernutrition
Aging
Keywords: Cancer
elderly
malnutrition
chemotherapy
survival
comprehensive geriatric assessment
morbidity
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
name: Ligue contre le cancer, France
First posted: 2007-04-12
Enrollment: 341
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Survival
timeFrame: 1 year
Secondary outcomes:
measure: Survival
timeFrame: 2 years
measure: toxicity of chemotherapy (NTC CTCv3 scale)
timeFrame: within 6 cycles of chemotherapy treatment,
measure: quality of life
timeFrame: before and after chemotherapy treatment
measure: biology (C-reactive protein [CRP], albumin, haemoglobin, creatinine clearance)
timeFrame: before and after treatment
measure: mood (GDS-15)
timeFrame: before and after treatment
measure: function: IADL, ADL, get up and go test
timeFrame: before and after treatment
measure: weight
timeFrame: before and after treatment
measure: MNA
timeFrame: before and after treatment
measure: dietary intakes
timeFrame: before and after treatment
measure: hospitalisation frequency
timeFrame: during treatment
measure: opportunistic infection frequency
timeFrame: during treatment
measure: fall, breaks, pressure sore
timeFrame: during treatment
measure: death
timeFrame: during treatment and at 2 years
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut Bergonié - 229 Cours de l'Argonne
city: Pessac
country: France
facility: Pôle de Gériatrie - CHU Bordeaux-Hôpital Xavier Arnozan - Avenue du Haut-Lévèque
Study officials:
affiliation: University Hospital, Bordeaux, France
name: Isabelle BOURDEL MARCHASSON, Pr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux, France
name: Geneviève CHENE, Pr.
role: STUDY_CHAIR
References:
citation: Bourdel-Marchasson I, Blanc-Bisson C, Doussau A, Germain C, Blanc JF, Dauba J, Lahmar C, Terrebonne E, Lecaille C, Ceccaldi J, Cany L, Lavau-Denes S, Houede N, Chomy F, Durrieu J, Soubeyran P, Senesse P, Chene G, Fonck M. Nutritional advice in older patients at risk of malnutrition during treatment for chemotherapy: a two-year randomized controlled trial. PLoS One. 2014 Sep 29;9(9):e108687. doi: 10.1371/journal.pone.0108687. eCollection 2014.