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Cancer, Nutrition and Taste (CANUT-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04216641
Recruitment Status : Not yet recruiting
First Posted : January 3, 2020
Last Update Posted : January 3, 2020
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.


Condition or disease Intervention/treatment Phase
Cancer Nutrition Disorders Dietary Supplement: Adapted food intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Impact of a Food Improvement Strategy on Their Appreciation in a Population of Cancer Patients Treated With Chemotherapy
Estimated Study Start Date : December 31, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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


  5. 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.

  6. 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.

  7. 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

  8. 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.

  9. 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.

  10. 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

  11. 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

  12. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04216641


Contacts
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Contact: David DAYDE, manager +33.4.78.86.37.74 ext +33 david.dayde@chu-lyon.fr
Contact: Nadjat MEDEGHRI, manager +33.4.78.86.37.74 ext +33 nadjat.medeghri@chu-lyon.fr

Sponsors and Collaborators
Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04216641    
Other Study ID Numbers: 69HCL19_0292
First Posted: January 3, 2020    Key Record Dates
Last Update Posted: January 3, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
cancer, nutrition disorder
Additional relevant MeSH terms:
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Nutrition Disorders