Impact of Early and Active Nutritional and Dietary Management grade3 or More Toxicities Induced by Chemotherapy and Targeted Therapies Administered to Patients as First Intention for Non Surgical Metastatic Colorectal Cancer (CHIMIODIET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01143285
Recruitment Status : Completed
First Posted : June 14, 2010
Last Update Posted : April 25, 2016
Centre Leon Berard
Centre Val d'Aurelle
University Hospital, Montpellier
Assistance Publique Hopitaux De Marseille
Centre hospitalier de Perpignan
Institut Sainte Catherine
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

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.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Other: Early and active nutritional support. Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Chimiodiet Study:Impact of Early and Active Nutritional and Dietary Management on grade3 or More Toxicities Induced by Chemotherapy and Targeted Therapies Administered to Patients as First Intention for Non Surgical Metastatic Colorectal Cancer.
Study Start Date : April 2010
Actual Primary Completion Date : December 2014
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: I - Early and active nutritional support.
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.
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.

No Intervention: II - No nutritional support
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.

Primary Outcome Measures :
  1. Toxicities frequently associated with chemotherapy [ Time Frame: 2 weeks ]
    Number and grade of: diarrhoea,nausea,vomiting, oral mucositis,fatigue, neurotoxicities, dysgeusia,haematological toxicities such as leukopenia neutropenia,anemia and thrombocytopenia.

Secondary Outcome Measures :
  1. Nutritional status of patients [ Time Frame: 2 weeks ]
    Measures: weight, body mass index

  2. Appetite measures [ Time Frame: 2 weeks ]
    Spontaneous food intake, EVA

  3. Quality of life [ Time Frame: 3 months ]
    questionary EORTC QLQ-C30

  4. Number of occurrences of grades 1 and 2 toxicities [ Time Frame: 2 weeks ]
  5. The number of hospital days [ Time Frame: All study ]
  6. Overall survival [ Time Frame: All study ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01143285

Institut Sainte Catherine
Avignon, France, 84082
The Léon Bérard Cancer Centre
Lyon, France, 69373
Assistance Publique des hopitaux de Marseille
Marseille, France, 13385
The Val d'Aurelle Cancer Centre
Montpellier, France, 34298
University Hospital, Montpellier
Montpellier, France, 34298
The Antoine Lacassagne Cancer Centre
Nice, France, 06000
The digestive oncology departement of the Archet Hospital of the Nice University Hospital Centre
Nice, France, 06202
Hospital in Perpignan
Perpignan, France
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Centre Leon Berard
Centre Val d'Aurelle
University Hospital, Montpellier
Assistance Publique Hopitaux De Marseille
Centre hospitalier de Perpignan
Institut Sainte Catherine
Principal Investigator: Xavier HEBUTERNE, PU-PH CHU de NICE

Additional Information:
1. Situation du cancer en France en 2007 - Synthèses rapports INCa - 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

Responsible Party: Centre Hospitalier Universitaire de Nice Identifier: NCT01143285     History of Changes
Other Study ID Numbers: 09-APN-03
First Posted: June 14, 2010    Key Record Dates
Last Update Posted: April 25, 2016
Last Verified: April 2016

Keywords provided by Centre Hospitalier Universitaire de Nice:
Active nutritional and dietary management
Metastatic colorectal cancer
Non surgical metastatic colorectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases