CAncer, NUtrition and Taste 2

Breast Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05027490
• Other study ID #: 69HCL21_0409
• Status: Completed
• Phase: N/A
• Start date: January 27, 2022
• Est. completion date: September 21, 2023

Study information

• Verified date: October 2023
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: September 21, 2023
• Est. primary completion date: September 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Bronchial Cancer
• Carcinoma, Bronchogenic
• Gynecologic Cancer

Intervention

Other:
• CANUT support
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 measures
These measures include weight, waist size, hip size and brachial circumference
• Prehension strength measurement
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

Behavioral:
• QVA Questionnaire
Food quality of life questionnaire
• QLQ C30 Questionnaire
Quality of Life questionnaire Core 30
• Scratch & Snif Test
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 Test
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 questionnaire
This questionnaire describes patient's food and drink intakes during the last 24 ours
• Condiment questionnaire
This questionnaire used to assess condiments consumption
• Tobacco questionnaire
This questionnaire used to assess tobacco consumption

Other:
• Nutrition interview
This interview will be conducted by a dietician

Locations

Country	Name	City	State
France	Hôpital Louis Pradel, Service gynécologie	Bron
France	Hôpital Louis Pradel, Service pneumologie	Bron
France	Infirmerie Protestante	Caluire-et-Cuire
France	Centre Léon Bérard, service gynécologie	Lyon
France	Centre Léon Bérard, service pneumologie	Lyon
France	Hôpital de la Croix Rousse, service pneumologie	Lyon
France	Centre hospitalo-universitaire de Lyon Sud, service Oncologie médicale	Pierre-Bénite
France	Centre hospitalo-universitaire de Lyon Sud, service pneumologie	Pierre-Bénite
France	CHU St Etienne,	Saint-Étienne
France	CH de Valence	Valence

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At the end of study follow-up, up to 12 weeks
Secondary	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.	At the end of study follow-up, up to 12 weeks
Secondary	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	At the end of study follow-up, up to 12 weeks
Secondary	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.	At the end of study follow-up, up to 12 weeks
Secondary	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.	At the end of study follow-up, up to 12 weeks
Secondary	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.	At the end of study follow-up, up to 12 weeks
Secondary	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.	At the end of study follow-up, up to 12 weeks
Secondary	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	At the end of study follow-up, up to 12 weeks
Secondary	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	At the end of study follow-up, up to 12 weeks
Secondary	Olfactory capacities	Olfactory capacities will be assessed thanks to the Scratch & Snif Test	At the end of study follow-up, up to 12 weeks
Secondary	Taste capacities	Taste capacities will be assessed thanks to the Taste Strip Test	At the end of study follow-up, up to 12 weeks
Secondary	Trigeminal sensitivity	Trigeminal sensitivity will be assessed thanks to a trigeminal sensitivity test	At the end of study follow-up, up to 12 weeks
Secondary	Use of CANUT guide	Changes in the frequency of use of the CANUT guide	At the end of study follow-up, up to 12 weeks
Secondary	Patient typology	Determining patient typology according to CITAS (Chemotherapy-induced Taste Alteration Scale) scale	At the end of study follow-up, up to 12 weeks
Secondary	Patient satisfaction	Determining patient satisfaction using a satisfaction questionnaire	At the end of study follow-up, up to 12 weeks