CancerINOGADNCT00459589
Nutritional Intervention in Geriatric Oncology
A study testing nutritional intervention with dietician plus usual nutritional care and usual nutritional care in people with Cancer and Undernutrition, run by University Hospital, Bordeaux at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Cancer, Undernutrition, Aging
- What is being tested?
- nutritional intervention with dietician plus usual nutritional care and usual nutritional care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 341 participants
- Where
- 2 sitesFrance
- Study dates
- Apr 2007to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Institut Bergonié - 229 Cours de l'Argonne
Bordeaux, 33076
Pôle de Gériatrie - CHU Bordeaux-Hôpital Xavier Arnozan - Avenue du Haut-Lévèque
Pessac, 33604
About this study
Official title: Nutritional Intervention in Geriatric Oncology in Patients at Risk of Undernutrition
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.
Read the 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
- Being tested
- nutritional intervention with dietician plus usual nutritional care, usual nutritional care
- Keywords
- Cancer, elderly, malnutrition, chemotherapy, survival, comprehensive geriatric assessment, morbidity
- Medical subject headings
- Neoplasms, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutritional intervention with dietician plus usual nutritional careBehavioural
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 careBehavioural
usual nutritional care
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: nutritional intervention with dietician plus usual nutritional care |
| 2 | Active comparator | Not described Receives: Behavioral: usual nutritional care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Measured: 1 year
Secondary outcomes (13)
Survival
Measured: 2 years
toxicity of chemotherapy (NTC CTCv3 scale)
Measured: within 6 cycles of chemotherapy treatment,
quality of life
Measured: before and after chemotherapy treatment
biology (C-reactive protein [CRP], albumin, haemoglobin, creatinine clearance)
Measured: before and after treatment
mood (GDS-15)
Measured: before and after treatment
function: IADL, ADL, get up and go test
Measured: before and after treatment
weight
Measured: before and after treatment
MNA
Measured: before and after treatment
dietary intakes
Measured: before and after treatment
hospitalisation frequency
Measured: during treatment
opportunistic infection frequency
Measured: during treatment
fall, breaks, pressure sore
Measured: during treatment
death
Measured: during treatment and at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2007 (estimated)
- Study startApr 2007
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 341 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France, Ligue contre le cancer, France
- Responsible party
- Sponsor
- Investigators
- Isabelle BOURDEL MARCHASSON, Pr., Principal investigator, University Hospital, Bordeaux, FranceGeneviève CHENE, Pr., Study chair, University Hospital, Bordeaux, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00459589
- Sponsor's protocol ID
- CHUBX 2006/11
- Other IDs
- 2006/018
- Acronym
- INOGAD
- Status last verified
- Jun 2012
- First submitted
- 11 Apr 2007
- Last updated
- 20 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25265392
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Intervention in Geriatric Oncology in Patients at Risk of Undernutrition
- ClinicalTrials.gov ID
- NCT00459589
- Acronym / sponsor ID
- INOGAD / CHUBX 2006/11
- Conditions
- Cancer, Undernutrition, Aging
- Keywords
- Cancer, elderly, malnutrition, chemotherapy, survival, comprehensive geriatric assessment, morbidity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 341 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Ministry of Health, France, Ligue contre le cancer, France
- Study start
- Apr 2007
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 12 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: nutritional intervention with dietician plus usual nutritional carenutritional 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 | Active comparator | Behavioral: usual nutritional care |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nutritional intervention with dietician plus usual nutritional carenutritional intervention with dietician at each cycle of chemotherapy in 6 first cycles to maintain 30 kcal/kg/d and 1.2 protein/kg/d | Behavioural | 1 |
| usual nutritional careusual nutritional care | Behavioural | 2 |
Primary outcome
Survival
Time frame: 1 year
13 secondary outcomes
Survival
Time frame: 2 years
toxicity of chemotherapy (NTC CTCv3 scale)
Time frame: within 6 cycles of chemotherapy treatment,
quality of life
Time frame: before and after chemotherapy treatment
biology (C-reactive protein [CRP], albumin, haemoglobin, creatinine clearance)
Time frame: before and after treatment
mood (GDS-15)
Time frame: before and after treatment
function: IADL, ADL, get up and go test
Time frame: before and after treatment
weight
Time frame: before and after treatment
MNA
Time frame: before and after treatment
dietary intakes
Time frame: before and after treatment
hospitalisation frequency
Time frame: during treatment
opportunistic infection frequency
Time frame: during treatment
fall, breaks, pressure sore
Time frame: during treatment
death
Time frame: during treatment and at 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2012.
- Derived from this study: PubMed 25265392Bourdel-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle BOURDEL MARCHASSON, Pr. principal investigator
University Hospital, Bordeaux, France
Geneviève CHENE, Pr. study chair
University Hospital, Bordeaux, France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nutritional intervention with dietician plus usual nutritional care and usual nutritional care in people with Cancer and Undernutrition, run by University Hospital, Bordeaux at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00459589, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2012.