Cancer, Nutrition and Taste (CANUT-1)

September 1, 2023 updated by: Hospices Civils de Lyon

Impact of a Food Improvement Strategy on Their Appreciation in a Population of Cancer Patients Treated With Chemotherapy

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
47

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Bron, France, 69677
        • Hopital Louis Pradel
      • Lyon, France, 69008
        • Centre Leon Berard
      • Lyon, France, 69004
        • Hôpital de jour - Hôpital de la Croix Rousse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention arm

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.
Dietary supplement: Adapted food intervention
Adapted food intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
proportion of treated patients by 4 cycles of chimiotherapy that will prefere at least 1 modified version of meal.
Time Frame: 12 weeks
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.
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Food assessment scores ( 0/4 to 4/4, 4 mean a better score)
Time Frame: Before Cycle 1(each cycle is 28 days) of chemotherapy treatment
Individual food assessment scores (standard food and adapted food to taste and smell disorders) before any treatment
Before Cycle 1(each cycle is 28 days) of chemotherapy treatment
Food assessment scores ( 0/4 to 4/4,4 mean a better score)
Time Frame: after 2 cycles (each cycle is 28 days) of chemotherapy
: Individual food assessment scores (standard food and adapted food to taste and smell disorders) after 2 cycles of chemotherapy
after 2 cycles (each cycle is 28 days) of chemotherapy
Food assessment scores ( 0/4 to 4/4, 4 mean a better score)
Time Frame: after 4 cycles(each cycle is 28 days) of chemotherapy
: Individual food assessment scores (standard food and adapted food to taste and smell disorders) after 4 cycles of chemotherapy
after 4 cycles(each cycle is 28 days) of chemotherapy
European Test of Olfactory Capabilities (ETOC) (1 (mean a worse) to 9 (mean a better)
Time Frame: Before cycle 1(each cycle is 28 days) of chemotherapy treatment

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
Before cycle 1(each cycle is 28 days) of chemotherapy treatment
European Test of Olfactory Capabilities (ETOC)(1 (mean a worse) to 9 (mean a better)
Time Frame: after 2 cycles (each cycle is 28 days) 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) after 2 of chemotherapy.
after 2 cycles (each cycle is 28 days) of chemotherapy
European Test of Olfactory Capabilities (ETOC)(1 (mean a worse) to 9 (mean a better)
Time Frame: after 4 cycles(each cycle is 28 days) 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) after and 4 cycles of chemotherapy.
after 4 cycles(each cycle is 28 days) of chemotherapy
Condiments consumption assessment by condiments questionnaire (0 contiment to 12 condiments)
Time Frame: Before cycle 1(each cycle is 28 days) of treatment
The number of condiments added at the time of inclusion
Before cycle 1(each cycle is 28 days) of treatment
Condiments consumption assessment by condiments questionnaire (0 contiment to 12 condiments)
Time Frame: after 2 cycles(each cycle is 28 days) of chemotherapy
The number of condiments added after 2 cycles of chemotherapy.
after 2 cycles(each cycle is 28 days) of chemotherapy
Condiments consumption assessment by condiments questionnaire (0 contiment to 12 condiments)
Time Frame: after 4 cycles(each cycle is 28 days) of chemotherapy
The number of condiments added after 4 cycles of chemotherapy.
after 4 cycles(each cycle is 28 days) of chemotherapy
Food temperature
Time Frame: Before Cycle 1(each cycle is 28 days) of chemotherapy treatment
The proportion of patients who prefer to consume cold foods versus those who prefer to consume hot foods at the time of inclusion
Before Cycle 1(each cycle is 28 days) of chemotherapy treatment
Food temperature
Time Frame: after 2 cycles(each cycle is 28 days) of chemotherapy
The proportion of patients who prefer to consume cold foods versus those who prefer to consume hot foods after 2 cycles of chemotherapy
after 2 cycles(each cycle is 28 days) of chemotherapy
Food temperature
Time Frame: after 4 cycles(each cycle is 28 days) of chemotherapy
The proportion of patients who prefer to consume cold foods versus those who prefer to consume hot foods at 4 cycles of chemotherapy
after 4 cycles(each cycle is 28 days) of chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 26, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 13, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 13, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 1, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 3, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 5, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 69HCL19_0292

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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