Nutritional Intervention in Geriatric Oncology (INOGAD)

This study has been completed.
Sponsor:
Collaborators:
Ministry of Health, France
Ligue contre le cancer, France
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00459589
First received: April 11, 2007
Last updated: June 19, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Cancer
Undernutrition
Aging
Behavioral: nutritional intervention with dietician plus usual nutritional care
Behavioral: usual nutritional care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Nutritional Intervention in Geriatric Oncology in Patients at Risk of Undernutrition

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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

Enrollment: 341
Study Start Date: April 2007
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
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
Active Comparator: 2 Behavioral: usual nutritional care
usual nutritional care

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

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00459589

Locations
France
Institut Bergonié - 229 Cours de l'Argonne
Bordeaux, France, 33076
Pôle de Gériatrie - CHU Bordeaux-Hôpital Xavier Arnozan - Avenue du Haut-Lévèque
Pessac, France, 33604
Sponsors and Collaborators
University Hospital, Bordeaux
Ministry of Health, France
Ligue contre le cancer, France
Investigators
Principal Investigator: Isabelle BOURDEL MARCHASSON, Pr. University Hospital, Bordeaux, France
Study Chair: Geneviève CHENE, Pr. University Hospital, Bordeaux, France
  More Information

No publications provided

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00459589     History of Changes
Other Study ID Numbers: CHUBX 2006/11, 2006/018
Study First Received: April 11, 2007
Last Updated: June 19, 2012
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Bordeaux:
Cancer
elderly
malnutrition
chemotherapy
survival
comprehensive geriatric assessment
morbidity

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on October 23, 2014