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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 recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Centre Hospitalier Universitaire de Nice.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
UNICANCER
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
ClinicalTrials.gov Identifier:
NCT01143285
First received: July 21, 2009
Last updated: February 22, 2013
Last verified: December 2011
  Purpose

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 Intervention
Metastatic Colorectal Cancer
Other: Early and active nutritional support.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • Toxicities frequently associated with chemotherapy [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Number and grade of: diarrhoea,nausea,vomiting, oral mucositis,fatigue, neurotoxicities, dysgeusia,haematological toxicities such as leukopenia neutropenia,anemia and thrombocytopenia.


Secondary Outcome Measures:
  • Nutritional status of patients [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Measures: weight, body mass index

  • Appetite measures [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Spontaneous food intake, EVA

  • Quality of life [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    questionary EORTC QLQ-C30

  • Number of occurrences of grades 1 and 2 toxicities [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • The number of hospital days [ Time Frame: All study ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: All study ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: April 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01143285

Contacts
Contact: Xavier HEBUTERNE, PU-PH 04 92 03 61 68 xavier.hebuterne@unice.fr
Contact: Cassandre LANDES, ARC 04 92 03 45 88 landes.c@chu-nice.fr

Locations
France
Institut Sainte Catherine Active, not recruiting
Avignon, France, 84082
The Léon Bérard Cancer Centre Recruiting
Lyon, France, 69373
Contact: Patrick Bachmann, PH    04 78 78 27 53    bachmann@lyon.fnclcc.fr   
Sub-Investigator: Patrick Bachmann, PH         
Assistance Publique des hopitaux de Marseille Recruiting
Marseille, France, 13385
Contact: Jean François Seitz, PH    04 91 38 60 23 ext +33    jean-francois.seitz@mail.ap-hm.fr   
Principal Investigator: Jean François Sietz, PH         
The Val d'Aurelle Cancer Centre Recruiting
Montpellier, France, 34298
Contact: Pierre Senesse, PH    04 67 61 85 54    psenesse@valdorel.fnclcc.fr   
Principal Investigator: Pierre Senesse, PH         
Sub-Investigator: Fabienne PORTALES, PH         
Sub-Investigator: Emmanuelle SAMALIN, PH         
University Hospital, Montpellier Recruiting
Montpellier, France, 34298
Contact: Pierre Senesse, PH       psenesse@valdorel.fnclcc.fr   
Principal Investigator: Pierre Senesse, PH         
Sub-Investigator: Delphine TOPART, PH         
The Antoine Lacassagne Cancer Centre Recruiting
Nice, France, 06000
Contact: Eric François, PH    04 92 03 10 00    eric.francois@nice.fnclcc.fr   
Sub-Investigator: Eric François, PH         
The digestive oncology departement of the Archet Hospital of the Nice University Hospital Centre Recruiting
Nice, France, 06202
Contact: Abakar Abakar-Mahamat, PH    04 92 03 60 21    mahamat.a@chu-nice.fr   
Sub-Investigator: Abakar Abakar-Mahamat, PH         
Sub-Investigator: Isabelle Besnard, PH         
Principal Investigator: Xavier Hébuterne, PU-PH         
Sub-Investigator: Ludovic EVESQUE, PH         
Hospital in Perpignan Active, not recruiting
Perpignan, France
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
UNICANCER
Centre Leon Berard
Centre Val d'Aurelle
University Hospital, Montpellier
Assistance Publique Hopitaux De Marseille
Centre hospitalier de Perpignan
Institut Sainte Catherine
Investigators
Principal Investigator: Xavier HEBUTERNE, PU-PH CHU de NICE
  More Information

Additional Information:
No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01143285     History of Changes
Other Study ID Numbers: 09-APN-03
Study First Received: July 21, 2009
Last Updated: February 22, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on November 27, 2014