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)
This study is currently recruiting participants.
Verified December 2011 by Centre Hospitalier Universitaire de Nice
Sponsor:
Centre Hospitalier Universitaire de Nice
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
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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
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 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 | |
| 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 | |
| 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 Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on May 19, 2013