CancerCANUT-1NCT04216641
Cancer, Nutrition and Taste
A study testing Adapted food intervention in people with Cancer and Nutrition Disorders, run by Hospices Civils de Lyon at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Nutrition Disorders
- What is being tested?
- Adapted food intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 3 sitesFrance
- Study dates
- 26 Feb 2020to 13 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hôpital Louis Pradel
Bron, 69677
Hôpital de jour - Hôpital de la Croix Rousse
Lyon, 69004
Centre Léon Bérard
Lyon, 69008
About this study
Official title: 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.
Read more
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.
- Conditions
- Cancer, Nutrition Disorders
- Being tested
- Adapted food intervention
- Keywords
- cancer, nutrition disorder
- Medical subject headings
- Neoplasms, Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted food interventionDietary supplement
Adapted food intervention
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | 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. Receives: Dietary Supplement: Adapted food intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (12)
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
Measured: Before Cycle 1(each cycle is 28 days) of chemotherapy 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
Measured: after 2 cycles (each cycle is 28 days) 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
Measured: 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)
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
Measured: 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)
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.
Measured: 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)
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.
Measured: after 4 cycles(each cycle is 28 days) of chemotherapy
Condiments consumption assessment by condiments questionnaire (0 contiment to 12 condiments)
The number of condiments added at the time of inclusion
Measured: Before cycle 1(each cycle is 28 days) of treatment
Condiments consumption assessment by condiments questionnaire (0 contiment to 12 condiments)
The number of condiments added after 2 cycles of chemotherapy.
Measured: after 2 cycles(each cycle is 28 days) of chemotherapy
Condiments consumption assessment by condiments questionnaire (0 contiment to 12 condiments)
The number of condiments added after 4 cycles of chemotherapy.
Measured: after 4 cycles(each cycle is 28 days) 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
Measured: Before Cycle 1(each cycle is 28 days) of chemotherapy treatment
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
Measured: after 2 cycles(each cycle is 28 days) 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
Measured: after 4 cycles(each cycle is 28 days) of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2020
- Study start26 Feb 2020
- Primary completion13 Jul 2022
- Study completion13 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04216641
- Sponsor's protocol ID
- 69HCL19_0292
- Acronym
- CANUT-1
- Status last verified
- Sep 2023
- First submitted
- 1 Oct 2019
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Food Improvement Strategy on Their Appreciation in a Population of Cancer Patients Treated With Chemotherapy
- ClinicalTrials.gov ID
- NCT04216641
- Acronym / sponsor ID
- CANUT-1 / 69HCL19_0292
- Conditions
- Cancer, Nutrition Disorders
- Keywords
- cancer, nutrition disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 26 Feb 2020 (actual)
- Primary completion
- 13 Jul 2022 (actual)
- Study completion
- 13 Jul 2022 (actual)
- First posted
- 3 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Dietary Supplement: Adapted food interventionAt 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adapted food interventionAdapted food intervention | Dietary supplement | Intervention arm |
Primary outcome
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 secondary outcomes
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
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
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
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
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
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
Condiments consumption assessment by condiments questionnaire (0 contiment to 12 condiments)
Time frame: 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
Condiments consumption assessment by condiments questionnaire (0 contiment to 12 condiments)
Time frame: 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
Food temperature
Time frame: after 2 cycles(each cycle is 28 days) of chemotherapy
Food temperature
Time frame: after 4 cycles(each cycle is 28 days) of chemotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted food intervention in people with Cancer and Nutrition Disorders, run by Hospices Civils de Lyon at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of treated patients by 4 cycles of chimiotherapy that will prefere at least 1 modified version of meal. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2023.