Back to resultsCancer, Nutrition and Taste (CANUT-1)
Primary Purpose
Cancer, Nutrition Disorders
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Adapted food intervention
Sponsored by
About this trial
This is an interventional health services research trial for Cancer focused on measuring cancer, nutrition disorder
Eligibility Criteria
Inclusion Criteria:
Patient with advanced lung cancer requiring a first line of intravenous chemotherapy or patient with localized, histologically or cytologically proven breast cancer for whom intravenous chemotherapy treatment will be initiated or patient with stage III-IV gynecological cancer (ovarian cancer or uterine cancer) for whom intravenous chemotherapy treatment will be initiated.
- Patient with a body mass index (BMI) between 18Kg/m² and 35Kg/m².
- Patient whose indication for treatment with intravenous chemotherapy has been selected
- Naive patient of previous chemotherapy.
- Life expectancy > 3 months.
- Patient able to travel for 4 visits to the Paul Bocuse Institute, 1 Chemin de Calabert, 69 130 ECULLY, FRANCE.
- Written informed consent obtained in accordance with applicable GCPs.
- Patients affiliated to a social security system.
- Patients who have the possibility of being accompanied, by the same person, to the visits of the test meals at the Paul Bocuse Research Institute
Exclusion Criteria:
- Patient under 18 years of age.
- Patient who has had another malignant tumor in the last 3 years.
- Patient with symptomatic brain metastases.
- Patient with symptomatic mucositis.
- Patient suffering or having suffered from an otorhinolaryngic or oesogastrointestinal pathology interfering with food intake.
- Patients with digestive disorders before any cancer treatment.
- Indication for concomitant radiotherapy or immunotherapy alone treatment.
- Patient with a known food allergy or food intolerance.
- Patient with partial or total agueusia diagnosed.
- Patient with diagnosed partial or total anosmia.
- Patients who have used artificial feeding within 2 months.
- Patients who have lost more than 10% of their baseline weight within 2 months.
- Patient unable to be regularly monitored for any reason
- Patient deprived of liberty or placed under guardianship or curatorship
- Pregnant or breastfeeding patient.
Sites / Locations
- Hôpital Louis Pradel
- Hôpital de jour - Hôpital de la Croix Rousse
- Centre Léon Bérard
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention arm
Arm Description
At each meal: different elements will be presented to the patient (starter / main course / side dish / dessert). For each of these elements, the patient will be offered 4 versions (a standard version and 3 adapted versions of the same food): The standard food. The food refers to a more elaborate texture. The food refers to a food with a stronger smell. The food refers to a more important flavor. The patient will indicate the version of the food that will be preferred.
Outcomes
Primary Outcome Measures
proportion of treated patients by 4 cycles of chimiotherapy that will prefere at least 1 modified version of meal.
The main endpoint of the CANUT-1 study is the proportion of cancer patients treated with chemotherapy (after 4 cycles) who will prefer at least an adapted version of a food compared to the standard version of the same food.
Secondary Outcome Measures
Food assessment scores ( 0/4 to 4/4, 4 mean a better score)
Individual food assessment scores (standard food and adapted food to taste and smell disorders) before any treatment
Food assessment scores ( 0/4 to 4/4,4 mean a better score)
: Individual food assessment scores (standard food and adapted food to taste and smell disorders) after 2 cycles of chemotherapy
Food assessment scores ( 0/4 to 4/4, 4 mean a better score)
: Individual food assessment scores (standard food and adapted food to taste and smell disorders) after 4 cycles of chemotherapy
European Test of Olfactory Capabilities (ETOC) (1 (mean a worse) to 9 (mean a better)
The results of olfactory detection and identification, familiarity, pleasantness, intensity, edibility and trigeminal perception (fresh, hot, irritant, pungent) European Test of Olfactory Capabilities (ETOC) before any treatment, after 2 and 4 cycles of chemotherapy.
The results of olfactory detection and identification, familiarity, pleasantness, intensity, edibility and trigeminal perception (fresh, hot, irritant, pungent) European Test of Olfactory Capabilities (ETOC) before any treatment
European Test of Olfactory Capabilities (ETOC)(1 (mean a worse) to 9 (mean a better)
The results of olfactory detection and identification, familiarity, pleasantness, intensity, edibility and trigeminal perception (fresh, hot, irritant, pungent) European Test of Olfactory Capabilities (ETOC) after 2 of chemotherapy.
European Test of Olfactory Capabilities (ETOC)(1 (mean a worse) to 9 (mean a better)
The results of olfactory detection and identification, familiarity, pleasantness, intensity, edibility and trigeminal perception (fresh, hot, irritant, pungent) European Test of Olfactory Capabilities (ETOC) after and 4 cycles of chemotherapy.
Condiments consumption assessment by condiments questionnaire (0 contiment to 12 condiments)
The number of condiments added at the time of inclusion
Condiments consumption assessment by condiments questionnaire (0 contiment to 12 condiments)
The number of condiments added after 2 cycles of chemotherapy.
Condiments consumption assessment by condiments questionnaire (0 contiment to 12 condiments)
The number of condiments added after 4 cycles of chemotherapy.
Food temperature
The proportion of patients who prefer to consume cold foods versus those who prefer to consume hot foods at the time of inclusion
Food temperature
The proportion of patients who prefer to consume cold foods versus those who prefer to consume hot foods after 2 cycles of chemotherapy
Food temperature
The proportion of patients who prefer to consume cold foods versus those who prefer to consume hot foods at 4 cycles of chemotherapy
Full Information
NCT ID
NCT04216641
First Posted
October 1, 2019
Last Updated
September 1, 2023
Sponsor
Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT04216641
Brief Title
Cancer, Nutrition and Taste
Acronym
CANUT-1
Official Title
Impact of a Food Improvement Strategy on Their Appreciation in a Population of Cancer Patients Treated With Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
February 26, 2020 (Actual)
Primary Completion Date
July 13, 2022 (Actual)
Study Completion Date
July 13, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Cancer promotes weight loss; it can also lead to particular complications for patients during treatment. A team led by Dr Michael Sawyer, showed the deleterious impact of undernutrition on the benefits of chemotherapy.
Cancer patients are at high risk of undernutrition, which is generally more pronounced for solid tumours (upper digestive tract, ENT, bronchial tubes…). This undernutrition leads to major weight loss and wasting, and may represent the first sign of a call for a diagnosis of cancer. Cancer-related undernutrition is multi-factorial in origin and has multiple consequences; it has its own prognostic value.
Chemotherapy treatments can induce various adverse effects in patients, including sensory disturbances at the beginning of treatment in addition to disturbances that may already be present before any treatment. Altered taste and odour, observed in 86% of patients, can induce a change in food preferences, promote the development of aversions, and therefore, lead to a significant reduction in the pleasure of eating. Loss of appetite, decreased food intake and the development of aversions to certain foods are situations experienced by a large proportion of patients undergoing chemotherapy.
The assessment of taste disorders in patients undergoing chemotherapy treatment is established through the use of questionnaires, interviews and taste tests.
Changes in the perception and identification of salty, sweet, bitter and sour flavours are common in patients undergoing chemotherapy.
The objective of CANUT is to study the effect of pathology and chemotherapy on gustatory and olfactory mechanisms and in particular on interindividual differences in the perception and appreciation of food.
In this study the investigators propose to adapt foods to best respond to sensory disorders related to the disease and/or treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Nutrition Disorders
Keywords
cancer, nutrition disorder
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
At each meal: different elements will be presented to the patient (starter / main course / side dish / dessert).
For each of these elements, the patient will be offered 4 versions (a standard version and 3 adapted versions of the same food):
The standard food.
The food refers to a more elaborate texture.
The food refers to a food with a stronger smell.
The food refers to a more important flavor.
The patient will indicate the version of the food that will be preferred.
Intervention Type
Dietary Supplement
Intervention Name(s)
Adapted food intervention
Intervention Description
Adapted food intervention
Primary Outcome Measure Information:
Title
proportion of treated patients by 4 cycles of chimiotherapy that will prefere at least 1 modified version of meal.
Description
The main endpoint of the CANUT-1 study is the proportion of cancer patients treated with chemotherapy (after 4 cycles) who will prefer at least an adapted version of a food compared to the standard version of the same food.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Food assessment scores ( 0/4 to 4/4, 4 mean a better score)
Description
Individual food assessment scores (standard food and adapted food to taste and smell disorders) before any treatment
Time Frame
Before Cycle 1(each cycle is 28 days) of chemotherapy treatment
Title
Food assessment scores ( 0/4 to 4/4,4 mean a better score)
Description
: Individual food assessment scores (standard food and adapted food to taste and smell disorders) after 2 cycles of chemotherapy
Time Frame
after 2 cycles (each cycle is 28 days) of chemotherapy
Title
Food assessment scores ( 0/4 to 4/4, 4 mean a better score)
Description
: Individual food assessment scores (standard food and adapted food to taste and smell disorders) after 4 cycles of chemotherapy
Time Frame
after 4 cycles(each cycle is 28 days) of chemotherapy
Title
European Test of Olfactory Capabilities (ETOC) (1 (mean a worse) to 9 (mean a better)
Description
The results of olfactory detection and identification, familiarity, pleasantness, intensity, edibility and trigeminal perception (fresh, hot, irritant, pungent) European Test of Olfactory Capabilities (ETOC) before any treatment, after 2 and 4 cycles of chemotherapy.
The results of olfactory detection and identification, familiarity, pleasantness, intensity, edibility and trigeminal perception (fresh, hot, irritant, pungent) European Test of Olfactory Capabilities (ETOC) before any treatment
Time Frame
Before cycle 1(each cycle is 28 days) of chemotherapy treatment
Title
European Test of Olfactory Capabilities (ETOC)(1 (mean a worse) to 9 (mean a better)
Description
The results of olfactory detection and identification, familiarity, pleasantness, intensity, edibility and trigeminal perception (fresh, hot, irritant, pungent) European Test of Olfactory Capabilities (ETOC) after 2 of chemotherapy.
Time Frame
after 2 cycles (each cycle is 28 days) of chemotherapy
Title
European Test of Olfactory Capabilities (ETOC)(1 (mean a worse) to 9 (mean a better)
Description
The results of olfactory detection and identification, familiarity, pleasantness, intensity, edibility and trigeminal perception (fresh, hot, irritant, pungent) European Test of Olfactory Capabilities (ETOC) after and 4 cycles of chemotherapy.
Time Frame
after 4 cycles(each cycle is 28 days) of chemotherapy
Title
Condiments consumption assessment by condiments questionnaire (0 contiment to 12 condiments)
Description
The number of condiments added at the time of inclusion
Time Frame
Before cycle 1(each cycle is 28 days) of treatment
Title
Condiments consumption assessment by condiments questionnaire (0 contiment to 12 condiments)
Description
The number of condiments added after 2 cycles of chemotherapy.
Time Frame
after 2 cycles(each cycle is 28 days) of chemotherapy
Title
Condiments consumption assessment by condiments questionnaire (0 contiment to 12 condiments)
Description
The number of condiments added after 4 cycles of chemotherapy.
Time Frame
after 4 cycles(each cycle is 28 days) of chemotherapy
Title
Food temperature
Description
The proportion of patients who prefer to consume cold foods versus those who prefer to consume hot foods at the time of inclusion
Time Frame
Before Cycle 1(each cycle is 28 days) of chemotherapy treatment
Title
Food temperature
Description
The proportion of patients who prefer to consume cold foods versus those who prefer to consume hot foods after 2 cycles of chemotherapy
Time Frame
after 2 cycles(each cycle is 28 days) of chemotherapy
Title
Food temperature
Description
The proportion of patients who prefer to consume cold foods versus those who prefer to consume hot foods at 4 cycles of chemotherapy
Time Frame
after 4 cycles(each cycle is 28 days) of chemotherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient with advanced lung cancer requiring a first line of intravenous chemotherapy or patient with localized, histologically or cytologically proven breast cancer for whom intravenous chemotherapy treatment will be initiated or patient with stage III-IV gynecological cancer (ovarian cancer or uterine cancer) for whom intravenous chemotherapy treatment will be initiated.
Patient with a body mass index (BMI) between 18Kg/m² and 35Kg/m².
Patient whose indication for treatment with intravenous chemotherapy has been selected
Naive patient of previous chemotherapy.
Life expectancy > 3 months.
Patient able to travel for 4 visits to the Paul Bocuse Institute, 1 Chemin de Calabert, 69 130 ECULLY, FRANCE.
Written informed consent obtained in accordance with applicable GCPs.
Patients affiliated to a social security system.
Patients who have the possibility of being accompanied, by the same person, to the visits of the test meals at the Paul Bocuse Research Institute
Exclusion Criteria:
Patient under 18 years of age.
Patient who has had another malignant tumor in the last 3 years.
Patient with symptomatic brain metastases.
Patient with symptomatic mucositis.
Patient suffering or having suffered from an otorhinolaryngic or oesogastrointestinal pathology interfering with food intake.
Patients with digestive disorders before any cancer treatment.
Indication for concomitant radiotherapy or immunotherapy alone treatment.
Patient with a known food allergy or food intolerance.
Patient with partial or total agueusia diagnosed.
Patient with diagnosed partial or total anosmia.
Patients who have used artificial feeding within 2 months.
Patients who have lost more than 10% of their baseline weight within 2 months.
Patient unable to be regularly monitored for any reason
Patient deprived of liberty or placed under guardianship or curatorship
Pregnant or breastfeeding patient.
Facility Information:
Facility Name
Hôpital Louis Pradel
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
Hôpital de jour - Hôpital de la Croix Rousse
City
Lyon
ZIP/Postal Code
69004
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69008
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Cancer, Nutrition and Taste
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