Nutritional Intervention in Geriatric Oncology

Cancer Clinical Trial

— INOGAD  

Official title:

Nutritional Intervention in Geriatric Oncology in Patients at Risk of Undernutrition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00459589
• Other study ID #: CHUBX 2006/11
• Secondary ID: 2006/018
• Status: Completed
• Phase: N/A
• First received: April 11, 2007
• Last updated: June 19, 2012
• Start date: April 2007
• Est. completion date: March 2012

Study information

• Verified date: June 2012
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 341
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Aging
• Cancer
• Malnutrition
• Undernutrition

Intervention

Behavioral:
• nutritional 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
• usual nutritional care
usual nutritional care

Locations

Country	Name	City	State
France	Institut Bergonié - 229 Cours de l'Argonne	Bordeaux
France	Pôle de Gériatrie - CHU Bordeaux-Hôpital Xavier Arnozan - Avenue du Haut-Lévèque	Pessac

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Ligue contre le cancer, France, Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival		1 year	No
Secondary	Survival		2 years	No
Secondary	toxicity of chemotherapy (NTC CTCv3 scale)		within 6 cycles of chemotherapy treatment,	No
Secondary	quality of life		before and after chemotherapy treatment	No
Secondary	biology (C-reactive protein [CRP], albumin, haemoglobin, creatinine clearance)		before and after treatment	No
Secondary	mood (GDS-15)		before and after treatment	No
Secondary	function: IADL, ADL, get up and go test		before and after treatment	No
Secondary	weight		before and after treatment	No
Secondary	MNA		before and after treatment	No
Secondary	dietary intakes		before and after treatment	No
Secondary	hospitalisation frequency		during treatment	No
Secondary	opportunistic infection frequency		during treatment	No
Secondary	fall, breaks, pressure sore		during treatment	No
Secondary	death		during treatment and at 2 years	No