Nutritional Intervention in Geriatric Oncology

Study Overview
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Brief Summary
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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
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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.

Official Title
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Nutritional Intervention in Geriatric Oncology in Patients at Risk of Undernutrition

Conditions
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Aging, Cancer, Undernutrition

Intervention / Treatment
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* Behavioral: nutritional intervention with dietician plus usual nutritional care
* Behavioral: usual nutritional care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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 | Behavioral: nutritional intervention with dietician plus usual nutritional care<br>* 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<br>|
| Active Comparator: 2<br> | Behavioral: usual nutritional care<br>* usual nutritional care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | 2 years | 
| toxicity of chemotherapy (NTC CTCv3 scale) |  | within 6 cycles of chemotherapy treatment, | 
| quality of life |  | before 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 test |  | before and after treatment | 
| weight |  | before and after treatment | 
| MNA |  | before and after treatment | 
| dietary intakes |  | before and after treatment | 
| hospitalisation frequency |  | during treatment | 
| opportunistic infection frequency |  | during treatment | 
| fall, breaks, pressure sore |  | during treatment | 
| death |  | during treatment and at 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, elderly, malnutrition, chemotherapy, survival, comprehensive geriatric assessment, morbidity