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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients receiving CANUT support (guide + dietary interviews) | Experimental | Patients included in this arm will have following interventions :
|
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| patients not receiving canut support (guide + dietary interviews) | Active Comparator | Patients included in this arm will have following interventions :
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CANUT support | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| QLQ-C30 score |
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Inclusion Criteria:
Major patient with one of the following 3 types of cancer:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Louis Pradel, Service gynécologie | Bron | 69677 | France | |||
| Hôpital Louis Pradel, Service pneumologie |
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| Anthropometric measures | Other | These measures include weight, waist size, hip size and brachial circumference |
|
| Prehension strength measurement | Other | 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 |
|
| QVA Questionnaire | Behavioral | Food quality of life questionnaire |
|
| QLQ C30 Questionnaire | Behavioral | Quality of Life questionnaire Core 30 |
|
| Scratch & Snif Test | Behavioral | 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 | Behavioral | 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 | Behavioral | This questionnaire describes patient's food and drink intakes during the last 24 ours |
|
| Condiment questionnaire | Behavioral | This questionnaire used to assess condiments consumption |
|
| Tobacco questionnaire | Behavioral | This questionnaire used to assess tobacco consumption |
|
| Nutrition interview | Other | This interview will be conducted by a dietician |
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Olfactory capacities | Olfactory capacities will be assessed thanks to the Scratch & Snif Test | At the end of study follow-up, up to 12 weeks |
| Taste capacities | Taste capacities will be assessed thanks to the Taste Strip Test | At the end of study follow-up, up to 12 weeks |
| Trigeminal sensitivity | Trigeminal sensitivity will be assessed thanks to a trigeminal sensitivity test | At the end of study follow-up, up to 12 weeks |
| 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 |
| 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 |
| Patient satisfaction | Determining patient satisfaction using a satisfaction questionnaire | At the end of study follow-up, up to 12 weeks |
| Bron |
| 69677 |
| France |
| Infirmerie Protestante | Caluire-et-Cuire | 69300 | France |
| Hôpital de la Croix Rousse, service pneumologie | Lyon | 69004 | France |
| Centre Léon Bérard, service gynécologie | Lyon | 69008 | France |
| Centre Léon Bérard, service pneumologie | Lyon | 69008 | France |
| Centre hospitalo-universitaire de Lyon Sud, service Oncologie médicale | Pierre-Bénite | 69310 | France |
| Centre hospitalo-universitaire de Lyon Sud, service pneumologie | Pierre-Bénite | 69310 | France |
| CHU St Etienne, | Saint-Etienne | 42270 | France |
| CH de Valence | Valence | 26 953 | France |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D002283 | Carcinoma, Bronchogenic |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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