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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

209

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline

Completed

Started Jan 2022

Geographic Reach

1 country

10 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.6 years study duration

First Submitted

Initial submission to the registry

August 19, 2021

Completed

11 days until next milestone

First Posted

Study publicly available on registry

August 30, 2021

Completed

5 months until next milestone

Study Start

First participant enrolled

January 27, 2022

Completed

1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2023

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2023

Completed

Last Updated

October 11, 2023

Status Verified

October 1, 2023

Enrollment Period

1.6 years

First QC Date

August 19, 2021

Last Update Submit

October 9, 2023

Conditions

Breast Cancer Gynecologic Cancer Bronchial Cancer Breast, Gynecological or Bronchial Cancer Treated With Intravenous Chemotherapy

Keywords

cancernutritionfood perceptions alterations

Outcome Measures

Primary Outcomes (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.
At the end of study follow-up, up to 12 weeks

Secondary Outcomes (14)

QVA questionnaire score
At the end of study follow-up, up to 12 weeks
QLQ-C30 score
At the end of study follow-up, up to 12 weeks
Weight
At the end of study follow-up, up to 12 weeks
waist size
At the end of study follow-up, up to 12 weeks
hip size
At the end of study follow-up, up to 12 weeks
+9 more secondary outcomes

Study Arms (2)

patients receiving CANUT support (guide + dietary interviews)

EXPERIMENTAL

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

Other: CANUT supportOther: Anthropometric measuresOther: Prehension strength measurementBehavioral: QVA QuestionnaireBehavioral: QLQ C30 QuestionnaireBehavioral: Scratch & Snif TestBehavioral: Taste Strip TestBehavioral: 24 H feed back questionnaireBehavioral: Condiment questionnaireBehavioral: Tobacco questionnaireOther: Nutrition interview

patients not receiving canut support (guide + dietary interviews)

ACTIVE COMPARATOR

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

Other: Anthropometric measuresOther: Prehension strength measurementBehavioral: QVA QuestionnaireBehavioral: QLQ C30 QuestionnaireBehavioral: Scratch & Snif TestBehavioral: Taste Strip TestBehavioral: 24 H feed back questionnaireBehavioral: Condiment questionnaireBehavioral: Tobacco questionnaireOther: Nutrition interview

Interventions

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.

patients receiving CANUT support (guide + dietary interviews)

Anthropometric measuresOTHER

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