AzTrials
AzTrials

Breast CancerCANUT-2NCT05027490

CAncer, NUtrition and Taste 2

A study testing CANUT support, Anthropometric measures and Prehension strength measurement in people with Breast Cancer and Gynecologic Cancer, run by Hospices Civils de Lyon at 10 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Although it has been established that the perception of food and eating and cooking habits change during cancer and its treatment, quality of life related to meals, which is an indicator of the psychobiological and physiological well-being of patients in their relationship to food, has been little studied in the… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CANUT support, Anthropometric measures and Prehension strength measurement
Could I receive a placebo?
No, everyone receives an active treatment
How many people
209 participants
Where
10 sitesFrance
Study dates
27 Jan 2022to 21 Sep 2023
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

  • Major patient with one of the following 3 types of cancer:
  • Stage 4 lung cancer (TNM 7 or 8). The indication for immunotherapy in addition to first line chemotherapy will not be a criterion for non-inclusion patients
  • histologically or cytologically proven localized breast cancer cytologically proven
  • Gynecological cancer (ovarian cancer or uterine cancer) stage III-IV without functional digestive signs related to the tumor disease
  • Patient with a body mass index (BMI) between 18 Kg/m² and 35 Kg/m².
  • Patient for whom the indication for treatment with a first line of intravenous chemotherapy (+/- targeted therapy) has been accepted by multidisciplinary meeting.
Show all 10Show fewer
  • Patient naive to previous chemotherapy.
  • Life expectancy > 3 months.
  • Patient with written informed consent
  • Patient affiliated to a French social security system.

Who cannot join

  • Patient under 18 years
  • Patient who had another malignancy within the last 3 years years, with the exception of carcinoma in situ of the cervix or cervical carcinoma in situ or adequately treated squamous cell carcinoma of the skin adequately treated, or basal cell skin cancer.This cancer must be adequately controlled.
  • Patients with symptomatic brain and/or meningeal metastases.
  • Patients with symptomatic mucositis.
  • Patients suffering or having suffered from an ear, nose and throat disease or oeso-gastro intestinal pathology interfering with the food intake.
  • Patients suffering from digestive disorders such as nausea prior to any cancer treatment.
Show all 15Show fewer
  • Indication of concomitant radiotherapy or immunotherapy treatment alone.
  • Patients with a known food allergy or intolerance
  • Patient with diagnosed partial or total ageusia.
  • Patient with diagnosed partial or total anosmia.
  • Patient having used artificial feeding in the 2 months prior to inclusion.
  • Patient who has lost more than 10% of baseline weight in the 2 months prior to inclusion.
  • Patient unable to be regularly followed for any reason (geographical, family, social, psychological,...).
  • Patient deprived of liberty or placed under guardianship or legal protection.
  • Pregnant or breastfeeding woman

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

France10 sites

  • Hôpital Louis Pradel, Service gynécologie

    Bron, 69677

  • Hôpital Louis Pradel, Service pneumologie

    Bron, 69677

  • Infirmerie Protestante

    Caluire-et-Cuire, 69300

  • Hôpital de la Croix Rousse, service pneumologie

    Lyon, 69004

  • Centre Léon Bérard, service gynécologie

    Lyon, 69008

  • Centre Léon Bérard, service pneumologie

    Lyon, 69008

  • Centre hospitalo-universitaire de Lyon Sud, service Oncologie médicale

    Pierre-Bénite, 69310

  • Centre hospitalo-universitaire de Lyon Sud, service pneumologie

    Pierre-Bénite, 69310

  • CHU St Etienne,

    Saint-Etienne, 42270

  • CH de Valence

    Valence, 26 953

Other trials in France

About this study

Official title: Impact of a Nutritional, Sensory and Culinary Support on the Improvement of the Quality of Life Related to Meals in Patients With Cancer Cancer Patients Treated With Chemotherapy

Although it has been established that the perception of food and eating and cooking habits change during cancer and its treatment, quality of life related to meals, which is an indicator of the psychobiological and physiological well-being of patients in their relationship to food, has been little studied in the pathological context, and particularly in patients undergoing chemotherapy.

Beyond its biological role, food plays a significant psychobiological and social role, as shown by a series of qualitative studies based on interviews with patients. Following a cancer diagnosis, loss of appetite, difficulty in sharing a meal with the family, and reduced pleasure in eating disrupt the patient's relationship with his or her food.

Read more

Thus, side effects such as fatigue, nausea and vomiting, and alterations in taste and smell induced by chemotherapy will affect patients' eating behavior, increasing the risk of deteriorating their quality of life with food. As these side effects are less known and therefore less expected by patients, they often lack the information and tools necessary to understand them.

The present study proposes a support for cancer patients treated by chemotherapy in order to improve their quality of life related to meals, and thus keep the pleasure of eating and reduce the risks of malnutrition. This support will consist of a guide provided to patients, in which they will have information on the functioning of the sensory systems involved in the eating experience, advice and culinary tips to adapt foods to their sensory disorders, and recipes that can be adapted in mild (for patients with hypersensitivity to tastes/smells), accentuated (for patients with hypersensitivity to tastes/smells) and enriched (for patients at risk of denutrition) versions. In addition, their sensory abilities will be assessed at the beginning of the study by psychophysical tests, then between each chemotherapy via a telephone interview (self-reported sensory abilities), and they will benefit from orientation according to the test results.

This work will be a first action to improve the quality of life related to the meal by information, follow-up, and adaptation of the meals to the sensory performances of each patient.

Being tested
CANUT support, Anthropometric measures, Prehension strength measurement, QVA Questionnaire, QLQ C30 Questionnaire
Keywords
cancer, nutrition, food perceptions alterations
Medical subject headings
Breast Neoplasms, Carcinoma, Bronchogenic, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CANUT supportOther

    CANUT support includes delivery of the CANUT guide (food guide developed by Paul Bocuse Institute from previous results) ; it will be given to patient with explanations about the use of the guide. This also includes 2 calls from a dietician, performed between the 1st and the 3rd chemotherapy cycle to help patient personally with their food side effects.

  • Anthropometric measuresOther

    These measures include weight, waist size, hip size and brachial circumference

  • Prehension strength measurementOther

    Prehension strength will be assessed thanks to a hand grip device, that makes it possible to measure strength of all fingers, hands, wrists and forearms muscles

  • QVA QuestionnaireBehavioural

    Food quality of life questionnaire

  • QLQ C30 QuestionnaireBehavioural

    Quality of Life questionnaire Core 30

  • Scratch & Snif TestBehavioural

    The Scratch \& Snif Test is used to assess olfactory capacities : patient has to scratch a box on a card, smell it and recognize the scent amongst a list of propositions

  • Taste Strip TestBehavioural

    The Taste Strip Test is used to assess taste capacities : strips impregnated with different concentrations of the 5 basic taste qualities (sweet, sour, acid, bitter, umami) are successively placed on patient's tongue ; patient has to identify the taste bit by bit.

  • 24 H feed back questionnaireBehavioural

    This questionnaire describes patient's food and drink intakes during the last 24 ours

  • Condiment questionnaireBehavioural

    This questionnaire used to assess condiments consumption

  • Tobacco questionnaireBehavioural

    This questionnaire used to assess tobacco consumption

  • Nutrition interviewOther

    This interview will be conducted by a dietician

Study groups in NCT05027490
Study groupRoleWhat they receive
patients receiving CANUT support (guide + dietary interviews)ExperimentalPatients included in this arm will have following interventions : * CANUT support : patients will receive the CANUT guide (food guide) to help them deal with eating disorders encountered during their chemotherapy treatment ; the CANUT support includes calls from a dietician between chemotherapy cycles for support and advice. * anthropometric measures * Prehension strength measurement * food quality of life questionnaire (Qualité de Vie Alimentaire QVA) * Quality of Life Questionnaire Core 30 (QLQ C30) * Scratch \& Snif Test * Taste Strip Test * Nutrition interview * 24 H feed back questionnaire * condiment questionnaire * tobacco questionnaire
Receives: Other: CANUT support; Other: Anthropometric measures; Other: Prehension strength measurement; Behavioral: QVA Questionnaire; Behavioral: QLQ C30 Questionnaire; Behavioral: Scratch & Snif Test; Behavioral: Taste Strip Test; Behavioral: 24 H feed back questionnaire; Behavioral: Condiment questionnaire; Behavioral: Tobacco questionnaire; Other: Nutrition interview
patients not receiving canut support (guide + dietary interviews)Active comparatorPatients included in this arm will have following interventions : * anthropometric measures * Prehension strength measurement * food quality of life questionnaire (Qualité de Vie Alimentaire QVA) * Quality of Life Questionnaire Core 30 (QLQ C30) * Scratch \& Snif Test * Taste Strip Test * Nutrition interview * 24 H feed back questionnaire * condiment questionnaire * tobacco questionnaire
Receives: Other: Anthropometric measures; Other: Prehension strength measurement; Behavioral: QVA Questionnaire; Behavioral: QLQ C30 Questionnaire; Behavioral: Scratch & Snif Test; Behavioral: Taste Strip Test; Behavioral: 24 H feed back questionnaire; Behavioral: Condiment questionnaire; Behavioral: Tobacco questionnaire; Other: Nutrition interview

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. QVA questionnaire score difference between the 2 arms

    The main endpoint of CANUT-2 is the comparison of the overall score of the food quality of life questionnaire (Qualité de Vie Alimentaire QVA) between patients who received CANUT support and those who did not receive the CANUT support. The comparison is performed at the time of V2 i.e. after 4 cycles of chemotherapy treatment, corresponding with the end of study follow-up.

    Measured: At the end of study follow-up, up to 12 weeks

Secondary outcomes (14)

  1. QVA questionnaire score

    Food questionnaire score QVA will be compared for each subsection between the 2 groups and between V1 (inclusion) and V2 (after 4 cycles of chemotherapy), according to the type of cancer.

    Measured: At the end of study follow-up, up to 12 weeks

  2. QLQ-C30 score

    Quality of life questionnaire score QLQ-C30 will be compared between the 2 arms and between V1 and V2, according to the type of cancer

    Measured: At the end of study follow-up, up to 12 weeks

  3. Weight

    Anthropometric parameters (weight, waist size, hip size and brachial circumference) associated with 24 H feedback questionnaire score and prehension strength, will make it possible to assess evolution of nutritional status between the 2 arms and between V1 and V2, according to the type of cancer.

    Measured: At the end of study follow-up, up to 12 weeks

  4. waist size

    Anthropometric parameters (weight, waist size, hip size and brachial circumference) associated with 24 H feedback questionnaire score and prehension strength, will make it possible to assess evolution of nutritional status between the 2 arms and between V1 and V2, according to the type of cancer.

    Measured: At the end of study follow-up, up to 12 weeks

  5. hip size

    Anthropometric parameters (weight, waist size, hip size and brachial circumference) associated with 24 H feedback questionnaire score and prehension strength, will make it possible to assess evolution of nutritional status between the 2 arms and between V1 and V2, according to the type of cancer.

    Measured: At the end of study follow-up, up to 12 weeks

  6. brachial circumference

    Anthropometric parameters (weight, waist size, hip size and brachial circumference) associated with 24 H feedback questionnaire score and prehension strength, will make it possible to assess evolution of nutritional status between the 2 arms and between V1 and V2, according to the type of cancer.

    Measured: At the end of study follow-up, up to 12 weeks

  7. Prehension strength

    This parameter, associated with anthropometric parameters and 24 H feedback questionnaire score, will make it possible to assess evolution of nutritional status between the 2 arms and between V1 and V2, according to the type of cancer

    Measured: At the end of study follow-up, up to 12 weeks

  8. 24 H feedback questionnaire score

    This parameter, associated with anthropometric parameters and prehension strength, will make it possible to assess evolution of nutritional status between the 2 arms and between V1 and V2, according to the type of cancer

    Measured: At the end of study follow-up, up to 12 weeks

  9. Olfactory capacities

    Olfactory capacities will be assessed thanks to the Scratch \& Snif Test

    Measured: At the end of study follow-up, up to 12 weeks

  10. Taste capacities

    Taste capacities will be assessed thanks to the Taste Strip Test

    Measured: At the end of study follow-up, up to 12 weeks

  11. Trigeminal sensitivity

    Trigeminal sensitivity will be assessed thanks to a trigeminal sensitivity test

    Measured: At the end of study follow-up, up to 12 weeks

  12. Use of CANUT guide

    Changes in the frequency of use of the CANUT guide

    Measured: At the end of study follow-up, up to 12 weeks

  13. Patient typology

    Determining patient typology according to CITAS (Chemotherapy-induced Taste Alteration Scale) scale

    Measured: At the end of study follow-up, up to 12 weeks

  14. Patient satisfaction

    Determining patient satisfaction using a satisfaction questionnaire

    Measured: At the end of study follow-up, up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2021
  2. Study start27 Jan 2022
  3. Primary completion21 Sep 2023
  4. Study completion21 Sep 2023

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
209 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05027490
Sponsor's protocol ID
69HCL21_0409
Acronym
CANUT-2
Status last verified
Oct 2023
First submitted
19 Aug 2021
Last updated
11 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Bagot S, Riantiningtyas RR, Drareni K, Roche M, Bruyas A, Riche B, Roux P, Mourier V, Nazare JA, Bensafi M, Giboreau A, Dougkas A. Effect of a Nutritional and Culinary Support Intervention on Food-Related Quality of Life During Chemotherapy. Clin Nutr ESPEN. 2026 Oct 21:105203. doi: 10.1016/j.clnesp.2026.105203. Online ahead of print.

    PubMed 42906880

Questions about this trial

What is this clinical trial studying?

A study testing CANUT support, Anthropometric measures and Prehension strength measurement in people with Breast Cancer and Gynecologic Cancer, run by Hospices Civils de Lyon at 10 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 10 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 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 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?

QVA questionnaire score difference between the 2 arms (time frame: At the end of study follow-up, up to 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05027490, which also lists 1 linked publication.

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 11 Oct 2023; AzTrials last refreshed its copy on 6 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in