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CAncer, NUtrition and Taste 2 (CANUT-2)

Primary Purpose

Breast Cancer, Gynecologic Cancer, Bronchial Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CANUT support
Anthropometric measures
Prehension strength measurement
QVA Questionnaire
QLQ C30 Questionnaire
Scratch & Snif Test
Taste Strip Test
24 H feed back questionnaire
Condiment questionnaire
Tobacco questionnaire
Nutrition interview
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Breast Cancer focused on measuring cancer, nutrition, food perceptions alterations

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.
  • Patient naive to previous chemotherapy.
  • Life expectancy > 3 months.
  • Patient with written informed consent
  • Patient affiliated to a French social security system.

Exclusion Criteria:

  • 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.
  • 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

Sites / Locations

  • Hôpital Louis Pradel, Service gynécologie
  • Hôpital Louis Pradel, Service pneumologie
  • Infirmerie Protestante
  • Hôpital de la Croix Rousse, service pneumologie
  • Centre Léon Bérard, service gynécologie
  • Centre Léon Bérard, service pneumologie
  • Centre hospitalo-universitaire de Lyon Sud, service Oncologie médicale
  • Centre hospitalo-universitaire de Lyon Sud, service pneumologie
  • CHU St Etienne,
  • CH de Valence

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

patients receiving CANUT support (guide + dietary interviews)

patients not receiving canut support (guide + dietary interviews)

Arm Description

Patients 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

Patients 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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
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.
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.
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.
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.
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
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
Olfactory capacities
Olfactory capacities will be assessed thanks to the Scratch & Snif Test
Taste capacities
Taste capacities will be assessed thanks to the Taste Strip Test
Trigeminal sensitivity
Trigeminal sensitivity will be assessed thanks to a trigeminal sensitivity test
Use of CANUT guide
Changes in the frequency of use of the CANUT guide
Patient typology
Determining patient typology according to CITAS (Chemotherapy-induced Taste Alteration Scale) scale
Patient satisfaction
Determining patient satisfaction using a satisfaction questionnaire

Full Information

First Posted
August 19, 2021
Last Updated
October 9, 2023
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT05027490
Brief Title
CAncer, NUtrition and Taste 2
Acronym
CANUT-2
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 27, 2022 (Actual)
Primary Completion Date
September 21, 2023 (Actual)
Study Completion Date
September 21, 2023 (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
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Gynecologic Cancer, Bronchial Cancer, Breast, Gynecological or Bronchial Cancer Treated With Intravenous Chemotherapy
Keywords
cancer, nutrition, food perceptions alterations

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
209 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients receiving CANUT support (guide + dietary interviews)
Arm Type
Experimental
Arm Description
Patients 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
Arm Title
patients not receiving canut support (guide + dietary interviews)
Arm Type
Active Comparator
Arm Description
Patients 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
Intervention Type
Other
Intervention Name(s)
CANUT support
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Anthropometric measures
Intervention Description
These measures include weight, waist size, hip size and brachial circumference
Intervention Type
Other
Intervention Name(s)
Prehension strength measurement
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
QVA Questionnaire
Intervention Description
Food quality of life questionnaire
Intervention Type
Behavioral
Intervention Name(s)
QLQ C30 Questionnaire
Intervention Description
Quality of Life questionnaire Core 30
Intervention Type
Behavioral
Intervention Name(s)
Scratch & Snif Test
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Taste Strip Test
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
24 H feed back questionnaire
Intervention Description
This questionnaire describes patient's food and drink intakes during the last 24 ours
Intervention Type
Behavioral
Intervention Name(s)
Condiment questionnaire
Intervention Description
This questionnaire used to assess condiments consumption
Intervention Type
Behavioral
Intervention Name(s)
Tobacco questionnaire
Intervention Description
This questionnaire used to assess tobacco consumption
Intervention Type
Other
Intervention Name(s)
Nutrition interview
Intervention Description
This interview will be conducted by a dietician
Primary Outcome Measure Information:
Title
QVA questionnaire score difference between the 2 arms
Description
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.
Time Frame
At the end of study follow-up, up to 12 weeks
Secondary Outcome Measure Information:
Title
QVA questionnaire score
Description
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.
Time Frame
At the end of study follow-up, up to 12 weeks
Title
QLQ-C30 score
Description
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
Time Frame
At the end of study follow-up, up to 12 weeks
Title
Weight
Description
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.
Time Frame
At the end of study follow-up, up to 12 weeks
Title
waist size
Description
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.
Time Frame
At the end of study follow-up, up to 12 weeks
Title
hip size
Description
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.
Time Frame
At the end of study follow-up, up to 12 weeks
Title
brachial circumference
Description
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.
Time Frame
At the end of study follow-up, up to 12 weeks
Title
Prehension strength
Description
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
Time Frame
At the end of study follow-up, up to 12 weeks
Title
24 H feedback questionnaire score
Description
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
Time Frame
At the end of study follow-up, up to 12 weeks
Title
Olfactory capacities
Description
Olfactory capacities will be assessed thanks to the Scratch & Snif Test
Time Frame
At the end of study follow-up, up to 12 weeks
Title
Taste capacities
Description
Taste capacities will be assessed thanks to the Taste Strip Test
Time Frame
At the end of study follow-up, up to 12 weeks
Title
Trigeminal sensitivity
Description
Trigeminal sensitivity will be assessed thanks to a trigeminal sensitivity test
Time Frame
At the end of study follow-up, up to 12 weeks
Title
Use of CANUT guide
Description
Changes in the frequency of use of the CANUT guide
Time Frame
At the end of study follow-up, up to 12 weeks
Title
Patient typology
Description
Determining patient typology according to CITAS (Chemotherapy-induced Taste Alteration Scale) scale
Time Frame
At the end of study follow-up, up to 12 weeks
Title
Patient satisfaction
Description
Determining patient satisfaction using a satisfaction questionnaire
Time Frame
At the end of study follow-up, up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Patient naive to previous chemotherapy. Life expectancy > 3 months. Patient with written informed consent Patient affiliated to a French social security system. Exclusion Criteria: 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. 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
Facility Information:
Facility Name
Hôpital Louis Pradel, Service gynécologie
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
Hôpital Louis Pradel, Service pneumologie
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
Infirmerie Protestante
City
Caluire-et-Cuire
ZIP/Postal Code
69300
Country
France
Facility Name
Hôpital de la Croix Rousse, service pneumologie
City
Lyon
ZIP/Postal Code
69004
Country
France
Facility Name
Centre Léon Bérard, service gynécologie
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Centre Léon Bérard, service pneumologie
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Centre hospitalo-universitaire de Lyon Sud, service Oncologie médicale
City
Pierre-Bénite
ZIP/Postal Code
69310
Country
France
Facility Name
Centre hospitalo-universitaire de Lyon Sud, service pneumologie
City
Pierre-Bénite
ZIP/Postal Code
69310
Country
France
Facility Name
CHU St Etienne,
City
Saint-Étienne
ZIP/Postal Code
42270
Country
France
Facility Name
CH de Valence
City
Valence
ZIP/Postal Code
26 953
Country
France

12. IPD Sharing Statement

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CAncer, NUtrition and Taste 2

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