CAncer, NUtrition and Taste 2

Not Applicable

Completed

• Conditions: Gynecologic Cancer; Breast Cancer; Breast, Gynecological or Bronchial Cancer Treated With Intravenous Chemotherapy; Bronchial Cancer
• Interventions: Other: CANUT support; Other: Anthropometric measures; Behavioral: QVA Questionnaire; Other: Prehension strength measurement; 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

• Registration Number: NCT05027490
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-08-19
• Study First Submitted QC: 2021-08-24
• Study First Posted: 2021-08-30
• Study Start: 2022-01-27
• Primary Completion: 2023-09-21
• Study Completion: 2023-09-21
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-09
• Last Update Posted: 2023-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 209

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patients receiving CANUT support (guide + dietary interviews)	Scratch & Snif Test	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 receiving CANUT support (guide + dietary interviews)	24 H feed back questionnaire	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 receiving CANUT support (guide + dietary interviews)	Nutrition interview	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 not receiving canut support (guide + dietary interviews)	Nutrition interview	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
patients receiving CANUT support (guide + dietary interviews)	Condiment questionnaire	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 receiving CANUT support (guide + dietary interviews)	Tobacco questionnaire	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 not receiving canut support (guide + dietary interviews)	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
patients receiving CANUT support (guide + dietary interviews)	Taste Strip Test	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 receiving CANUT support (guide + dietary interviews)	CANUT support	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 not receiving canut support (guide + dietary interviews)	QVA 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
patients receiving CANUT support (guide + dietary interviews)	Anthropometric measures	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 receiving CANUT support (guide + dietary interviews)	Prehension strength measurement	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 receiving CANUT support (guide + dietary interviews)	QVA Questionnaire	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 receiving CANUT support (guide + dietary interviews)	QLQ C30 Questionnaire	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 not receiving canut support (guide + dietary interviews)	Anthropometric measures	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
patients not receiving canut support (guide + dietary interviews)	Scratch & Snif Test	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
patients not receiving canut support (guide + dietary interviews)	Taste Strip Test	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
patients not receiving canut support (guide + dietary interviews)	Prehension strength measurement	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
patients not receiving canut support (guide + dietary interviews)	QLQ C30 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
patients not receiving canut support (guide + dietary interviews)	24 H feed back 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
patients not receiving canut support (guide + dietary interviews)	Condiment 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

Primary Outcome Measures

Name	Time	Method
QVA questionnaire score difference between the 2 arms	At the end of study follow-up, up to 12 weeks	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

Name	Time	Method
QVA questionnaire score	At the end of study follow-up, up to 12 weeks	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.
brachial circumference	At the end of study follow-up, up to 12 weeks	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	At the end of study follow-up, up to 12 weeks	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.
Olfactory capacities	At the end of study follow-up, up to 12 weeks	Olfactory capacities will be assessed thanks to the Scratch \& Snif Test
Taste capacities	At the end of study follow-up, up to 12 weeks	Taste capacities will be assessed thanks to the Taste Strip Test
Trigeminal sensitivity	At the end of study follow-up, up to 12 weeks	Trigeminal sensitivity will be assessed thanks to a trigeminal sensitivity test
Use of CANUT guide	At the end of study follow-up, up to 12 weeks	Changes in the frequency of use of the CANUT guide
QLQ-C30 score	At the end of study follow-up, up to 12 weeks	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
Patient satisfaction	At the end of study follow-up, up to 12 weeks	Determining patient satisfaction using a satisfaction questionnaire
hip size	At the end of study follow-up, up to 12 weeks	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	At the end of study follow-up, up to 12 weeks	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	At the end of study follow-up, up to 12 weeks	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
Patient typology	At the end of study follow-up, up to 12 weeks	Determining patient typology according to CITAS (Chemotherapy-induced Taste Alteration Scale) scale
Weight	At the end of study follow-up, up to 12 weeks	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.

Trial Locations

Locations (10)

Hôpital Louis Pradel, Service gynécologie; 🇫🇷 Bron, France

Centre hospitalo-universitaire de Lyon Sud, service Oncologie médicale; 🇫🇷 Pierre-Bénite, France

Hôpital Louis Pradel, Service pneumologie; 🇫🇷 Bron, France

CH de Valence; 🇫🇷 Valence, France

Centre Léon Bérard, service pneumologie; 🇫🇷 Lyon, France

Infirmerie Protestante; 🇫🇷 Caluire-et-Cuire, France

Centre hospitalo-universitaire de Lyon Sud, service pneumologie; 🇫🇷 Pierre-Bénite, France

Centre Léon Bérard, service gynécologie; 🇫🇷 Lyon, France

CHU St Etienne,; 🇫🇷 Saint-Étienne, France

Hôpital de la Croix Rousse, service pneumologie; 🇫🇷 Lyon, France