Nutritional Intervention in Geriatric Oncology

NCT ID: NCT00459589

Last Updated: 2012-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 341 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2012-03-31

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.

Conditions

Cancer; Undernutrition; Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1

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

Group Type: EXPERIMENTAL

nutritional intervention with dietician plus usual nutritional care

Intervention Type: BEHAVIORAL

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

2

Group Type: ACTIVE_COMPARATOR

usual nutritional care

Intervention Type: BEHAVIORAL

usual nutritional care

Interventions

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

Intervention Type: BEHAVIORAL

usual nutritional care

usual nutritional care

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, France

OTHER_GOV

Sponsor Role: collaborator

Ligue contre le cancer, France

OTHER

Sponsor Role: collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Isabelle BOURDEL MARCHASSON, Pr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux, France

Geneviève CHENE, Pr.

Role: STUDY_CHAIR

University Hospital, Bordeaux, France

Locations

Institut Bergonié - 229 Cours de l'Argonne

Bordeaux, , France

Pôle de Gériatrie - CHU Bordeaux-Hôpital Xavier Arnozan - Avenue du Haut-Lévèque

Pessac, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 25265392 (View on PubMed)

Other Identifiers

2006/018

Identifier Type: -

Identifier Source: secondary_id

CHUBX 2006/11

Identifier Type: -

Identifier Source: org_study_id