Study Results
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Basic Information
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COMPLETED
NA
209 participants
INTERVENTIONAL
2022-01-27
2023-09-21
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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patients receiving CANUT support (guide + dietary interviews)
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
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
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
Nutrition interview
This interview will be conducted by a dietician
patients not receiving canut support (guide + dietary interviews)
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
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
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
Nutrition interview
This interview will be conducted by a dietician
Interventions
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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
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
Nutrition interview
This interview will be conducted by a dietician
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Locations
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Hôpital Louis Pradel, Service gynécologie
Bron, , France
Hôpital Louis Pradel, Service pneumologie
Bron, , France
Infirmerie Protestante
Caluire-et-Cuire, , France
Hôpital de la Croix Rousse, service pneumologie
Lyon, , France
Centre Léon Bérard, service gynécologie
Lyon, , France
Centre Léon Bérard, 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-Etienne, , France
CH de Valence
Valence, , France
Countries
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Other Identifiers
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69HCL21_0409
Identifier Type: -
Identifier Source: org_study_id
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