NCT00459589

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
341

participants targeted

Target at P75+ for not_applicable cancer

Timeline
Completed

Started Apr 2007

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

April 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 12, 2007

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

June 20, 2012

Status Verified

June 1, 2012

Enrollment Period

4.9 years

First QC Date

April 11, 2007

Last Update Submit

June 19, 2012

Conditions

CancerUndernutritionAging

Keywords

Cancerelderlymalnutritionchemotherapysurvivalcomprehensive geriatric assessmentmorbidity

Outcome Measures

Primary Outcomes (1)

  • Survival

    1 year

Secondary Outcomes (13)

  • 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

  • +8 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

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

2

ACTIVE COMPARATOR
Behavioral: usual nutritional care

Interventions

nutritional intervention with dietician plus usual nutritional careBEHAVIORAL

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

1
usual nutritional careBEHAVIORAL

usual nutritional care

2

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Institut Bergonié - 229 Cours de l'Argonne

Bordeaux, 33076, France

Location

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

Pessac, 33604, France

Location

Related Publications (1)

  • 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.

    PMID: 25265392DERIVED

MeSH Terms

Conditions

NeoplasmsMalnutrition

Interventions

Nutritionists

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Health PersonnelHealth Care Facilities Workforce and Services

Study Officials

  • Isabelle BOURDEL MARCHASSON, Pr.

    University Hospital, Bordeaux, France

    PRINCIPAL INVESTIGATOR

  • Geneviève CHENE, Pr.

    University Hospital, Bordeaux, France

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2007

First Posted

April 12, 2007

Study Start

April 1, 2007

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

June 20, 2012

Record last verified: 2012-06

Locations

FR(2)