NCT01143285

Brief Summary

Description of active nutritional support: Early and active nutritional support is mainly concerned with maintaining protein and energy intake levels despite chemotherapy. A part-time nutritionist will be assigned to each research centre. She will cover active nutritional support during a one-hour consultation and assist the investigating oncologist in filling out the e-CRF data. A two-day meeting prior to the beginning of the study will enable the standardization of active nutritional support strategy across all research centres:

  • The nutritionist will explain the consequences of the side effects of chemotherapy on appetite levels and nutritional status.
  • Spontaneous oral intake and eating habits will be assessed based on a qualitative and quantitative 3-day food record.
  • Then the nutritionist will explain to patients how to adapt their diet (fortification, portion control etc.) according to personal preferences and dietary habits, appetite fluctuation and side effects.
  • A booklet containing an overview of the nutritional counsel, recipe ideas, an example of a daily menu, energy equivalence tables and specific diet and hygiene tips for each possible side effects of chemotherapy will be given to all patients.
  • During each consultation, patients will be weighed, appetite and food intake will be evaluated (24-hour record except for prospective 3-day record of V0, V3, V6, V9, V12, V13 and V14 consultations), chemotherapy side effects will be recorded and nutritional counsel will be adapted to each patient's individual situation. In case of decrease in food intake and/or weight loss, a protein- and energy-rich oral supplement will be given. In both groups, if a patient exhibits signs of malnutrition (weight loss \>5% over a one-month period or \> 10% in total) and/or food intake less than 50% of estimated daily requirements, an oral supplement will be given after approval of the oncologist. If this measure is insufficient, artificial nutrition (enteral or parenteral) will be considered.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

8 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

First Submitted

Initial submission to the registry

July 21, 2009

Completed
8 months until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 14, 2010

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

April 25, 2016

Status Verified

April 1, 2016

Enrollment Period

4.7 years

First QC Date

July 21, 2009

Last Update Submit

April 22, 2016

Conditions

Metastatic Colorectal Cancer

Keywords

Active nutritional and dietary managementMetastatic colorectal cancerNon surgical metastatic colorectal cancer

Outcome Measures

Primary Outcomes (1)

  • Toxicities frequently associated with chemotherapy

    Number and grade of: diarrhoea,nausea,vomiting, oral mucositis,fatigue, neurotoxicities, dysgeusia,haematological toxicities such as leukopenia neutropenia,anemia and thrombocytopenia.

    2 weeks

Secondary Outcomes (6)

  • Nutritional status of patients

    2 weeks

  • Appetite measures

    2 weeks

  • Quality of life

    3 months

  • Number of occurrences of grades 1 and 2 toxicities

    2 weeks

  • The number of hospital days

    All study

  • +1 more secondary outcomes

Study Arms (2)

I - Early and active nutritional support.

EXPERIMENTAL

During the initial consultation, the dietician will answer the questions of the patient and their family. Patients will be seen regularly in follow-up for weight measurement, serum albumin assay, a 1 or 3 day food record and an evaluation of appetite level. Nutritional counselling is then adjusted accordingly and:Balanced meals are continued if weight is stable and appetite is undiminished.Protein and energy fortification is recommended if weight loss is observed or if food intake decreases between 2 consultations leading to total food intake of less than 50% of required food intake. When a patient presents with signs of malnutrition according to the criteria set out by the Authority for Health, oral nutritional support (ONS) is set up, in agreement with the department head. Two 200ml bottles of Fortimel Extra are to be taken every day. If this ONS strategy is insufficient to improve the patient's nutritional status, artificial nutrition should be discussed.

Other: Early and active nutritional support.

II - No nutritional support

NO INTERVENTION

Should malnutrition develop in a group II patient, ONS will be ordered. It will consist of two 200ml Fortimel Extra\* bottles per day in addition to regular meals. Ideally, the ONS should be taken as a snack outside of meal times so as to not spoil the appetite. If this ONS is insufficient to improve the nutritional status of the patient, artificial nutrition (either enteral or parenteral) will be discussed.

Interventions

Early and active nutritional support.OTHER

The first nutritional consultation coincides with the 1st CT consultation. An overview of the nutritional support strategy is given, along with specific goals and the twice monthly follow-up schedule that accompanies the chemotherapy courses. The nutritionist once again goes over the various side effects of the medication. Special attention will be given to digestive side effects and their consequences on appetite levels and weight loss during treatment.A qualitative and quantitative 3-day food record will precede the 1st course of CT. This food record is given to patients during the 1st selection visit, in order to evaluate spontaneous oral food intake and dietary habits. Information from the different food groups serves as a starting point for the dietician to explain how to adapt food intake through fortification, portion control according to appetite fluctuations and the onset of side effects.

I - Early and active nutritional support.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over 18 years of age
  • Patients with synchrone or metachronous CRC metastases without possible initial surgical outcome
  • Patients covered by Social Security
  • Patients willing to sign the proper consent forms

You may not qualify if:

  • Severely malnourished patients according to the Authority for Health criteria : weight loss \> 5% of base weight in less than one month or \> 10% of base weight in less than six months and/or BMI \< 18 or 21.5 in patients 70 years old or more, and/or serum albumin assay \< 35 g/l.
  • Patients receiving concomitant radiotherapy.
  • Patients receiving or programmed to receive artificial nutrition (enteral or parenteral).
  • Pregnant or breastfeeding women (a qualitative urine pregnancy test will be given to all women of child-bearing age).
  • Patients incapable of understanding (foreign language, intellectual deficiencies, motor cortex deficiencies...) and/or applying the nutritional counselling (persons institutionalised in a rest home, retirement home, prison etc.).
  • Patients with another sever debilitating disease likely to impact on nutritional status (cardiac, hepatic, or renal insufficiency etc.).
  • Persons already participating in another clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Institut Sainte Catherine

Avignon, 84082, France

Location

The Léon Bérard Cancer Centre

Lyon, 69373, France

Location

Assistance Publique des hopitaux de Marseille

Marseille, 13385, France

Location

The Val d'Aurelle Cancer Centre

Montpellier, 34298, France

Location

University Hospital, Montpellier

Montpellier, 34298, France

Location

The Antoine Lacassagne Cancer Centre

Nice, 06000, France

Location

The digestive oncology departement of the Archet Hospital of the Nice University Hospital Centre

Nice, 06202, France

Location

Hospital in Perpignan

Perpignan, France

Location

Related Publications (1)

  • 1. Situation du cancer en France en 2007 - Synthèses rapports INCa - http://www.e-cancer.fr 2.Dewys et al.,Pronostic effect of weight loss prior to CT in cancer patient. Am J.Med 1980; 69 (4): 491-7; 3. Étude Nutricancer 2005, Hébuterne et al, Nutr Clin Metabol 2006.4.Gupta D, Lis CG, Granick J, Grutsch JF, Vashi PG, Lammersfeld CA. Malnutrition associated with poor quality of life in CR cancer:retrospective analysis.J Clin Epidemiol 2006 Jul;59(7):704-9. Epub 2006 Apr 19. 5. Andreyev et al., Why do patients with weight loss have a worse outcome when undergoing CT for gastrointestinal malignancies, Eur J Cancer 1998 Mar; 34(4): 503-9;6. Schneider et al, Malnutrition is an independant factor associated with nosocomial infections, Br J Nutr 2004 Jul; 92(1): 105-11. 7.Tucker HN, Miquel SG. : cost containment through nutrition intervention. Nutr Rev 1996 Apr; 54: 111-21.8. Colucci G, Gebbia V, Paoletti G, Giuliani F, Caruso M, Gebbia N et al . Gruppo Oncologico Dell'Italia Meridionale. Phase III randomized trial of FOLFIRI VS FOLFOX4 in the treatment of advanced CCR: a multicenter study of the Gruppo Oncologico Dell'Italia Meridionale. J Clin Oncol. 2005 Aug 1;23(22):4866-75. Epub 2005 Jun 6.9. Douillard JY, Sobrero A, Carnaghi C, Comella P, Díaz-Rubio E, Santoro A et al. Metastatic CR cancer: integrating irinotecan into combination and sequential CT. Ann Oncol. 2003;14 Suppl 2:ii7-12. Review.10. Hurwitz HI, Fehrenbacher L, Hainsworth JD, Heim W, Berlin J, Holmgren E et al. Bevacizumab in combination with fluorouracil and leucovorin: an active regimen for first-line metastatic colorectal cancer.J Clin Oncol. 2005 May 20;23(15):3502-8.11. Saltz LB, Meropol NJ, Loehrer PJ Sr, Needle MN, Kopit J, Mayer RJ. Phase II trial of cetuximab in patients with refractory CR cancer that expresses the epidermal growth factor receptor. J Clin Oncol. 2004 Apr 1;22(7):1201-8. Epub 2004 Mar 1

    BACKGROUND

Related Links

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Xavier HEBUTERNE, PU-PH

    Centre Hospitalier Universitaire de Nice

    PRINCIPAL INVESTIGATOR

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

July 21, 2009

First Posted

June 14, 2010

Study Start

April 1, 2010

Primary Completion

December 1, 2014

Study Completion

April 1, 2016

Last Updated

April 25, 2016

Record last verified: 2016-04

Locations

FR(8)