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Cancer promotes weight loss; it can also lead to particular complications for patients during treatment. A team led by Dr Michael Sawyer, showed the deleterious impact of undernutrition on the benefits of chemotherapy.
Cancer patients are at high risk of undernutrition, which is generally more pronounced for solid tumours (upper digestive tract, ENT, bronchial tubes…). This undernutrition leads to major weight loss and wasting, and may represent the first sign of a call for a diagnosis of cancer. Cancer-related undernutrition is multi-factorial in origin and has multiple consequences; it has its own prognostic value.
Chemotherapy treatments can induce various adverse effects in patients, including sensory disturbances at the beginning of treatment in addition to disturbances that may already be present before any treatment. Altered taste and odour, observed in 86% of patients, can induce a change in food preferences, promote the development of aversions, and therefore, lead to a significant reduction in the pleasure of eating. Loss of appetite, decreased food intake and the development of aversions to certain foods are situations experienced by a large proportion of patients undergoing chemotherapy.
The assessment of taste disorders in patients undergoing chemotherapy treatment is established through the use of questionnaires, interviews and taste tests.
Changes in the perception and identification of salty, sweet, bitter and sour flavours are common in patients undergoing chemotherapy.
The objective of CANUT is to study the effect of pathology and chemotherapy on gustatory and olfactory mechanisms and in particular on interindividual differences in the perception and appreciation of food.
In this study the investigators propose to adapt foods to best respond to sensory disorders related to the disease and/or treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Experimental | At each meal: different elements will be presented to the patient (starter / main course / side dish / dessert). For each of these elements, the patient will be offered 4 versions (a standard version and 3 adapted versions of the same food):
The patient will indicate the version of the food that will be preferred. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adapted food intervention | Dietary Supplement | Adapted food intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| proportion of treated patients by 4 cycles of chimiotherapy that will prefere at least 1 modified version of meal. | The main endpoint of the CANUT-1 study is the proportion of cancer patients treated with chemotherapy (after 4 cycles) who will prefer at least an adapted version of a food compared to the standard version of the same food. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Food assessment scores ( 0/4 to 4/4, 4 mean a better score) | Individual food assessment scores (standard food and adapted food to taste and smell disorders) before any treatment | Before Cycle 1(each cycle is 28 days) of chemotherapy treatment |
| Food assessment scores ( 0/4 to 4/4,4 mean a better score) |
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Inclusion Criteria:
Patient with advanced lung cancer requiring a first line of intravenous chemotherapy or patient with localized, histologically or cytologically proven breast cancer for whom intravenous chemotherapy treatment will be initiated or patient with stage III-IV gynecological cancer (ovarian cancer or uterine cancer) for whom intravenous chemotherapy treatment will be initiated.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Louis Pradel | Bron | 69677 | France | |||
| Hôpital de jour - Hôpital de la Croix Rousse |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D009748 | Nutrition Disorders |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
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: Individual food assessment scores (standard food and adapted food to taste and smell disorders) after 2 cycles of chemotherapy |
| after 2 cycles (each cycle is 28 days) of chemotherapy |
| Food assessment scores ( 0/4 to 4/4, 4 mean a better score) | : Individual food assessment scores (standard food and adapted food to taste and smell disorders) after 4 cycles of chemotherapy | after 4 cycles(each cycle is 28 days) of chemotherapy |
| European Test of Olfactory Capabilities (ETOC) (1 (mean a worse) to 9 (mean a better) | The results of olfactory detection and identification, familiarity, pleasantness, intensity, edibility and trigeminal perception (fresh, hot, irritant, pungent) European Test of Olfactory Capabilities (ETOC) before any treatment, after 2 and 4 cycles of chemotherapy. The results of olfactory detection and identification, familiarity, pleasantness, intensity, edibility and trigeminal perception (fresh, hot, irritant, pungent) European Test of Olfactory Capabilities (ETOC) before any treatment | Before cycle 1(each cycle is 28 days) of chemotherapy treatment |
| European Test of Olfactory Capabilities (ETOC)(1 (mean a worse) to 9 (mean a better) | The results of olfactory detection and identification, familiarity, pleasantness, intensity, edibility and trigeminal perception (fresh, hot, irritant, pungent) European Test of Olfactory Capabilities (ETOC) after 2 of chemotherapy. | after 2 cycles (each cycle is 28 days) of chemotherapy |
| European Test of Olfactory Capabilities (ETOC)(1 (mean a worse) to 9 (mean a better) | The results of olfactory detection and identification, familiarity, pleasantness, intensity, edibility and trigeminal perception (fresh, hot, irritant, pungent) European Test of Olfactory Capabilities (ETOC) after and 4 cycles of chemotherapy. | after 4 cycles(each cycle is 28 days) of chemotherapy |
| Condiments consumption assessment by condiments questionnaire (0 contiment to 12 condiments) | The number of condiments added at the time of inclusion | Before cycle 1(each cycle is 28 days) of treatment |
| Condiments consumption assessment by condiments questionnaire (0 contiment to 12 condiments) | The number of condiments added after 2 cycles of chemotherapy. | after 2 cycles(each cycle is 28 days) of chemotherapy |
| Condiments consumption assessment by condiments questionnaire (0 contiment to 12 condiments) | The number of condiments added after 4 cycles of chemotherapy. | after 4 cycles(each cycle is 28 days) of chemotherapy |
| Food temperature | The proportion of patients who prefer to consume cold foods versus those who prefer to consume hot foods at the time of inclusion | Before Cycle 1(each cycle is 28 days) of chemotherapy treatment |
| Food temperature | The proportion of patients who prefer to consume cold foods versus those who prefer to consume hot foods after 2 cycles of chemotherapy | after 2 cycles(each cycle is 28 days) of chemotherapy |
| Food temperature | The proportion of patients who prefer to consume cold foods versus those who prefer to consume hot foods at 4 cycles of chemotherapy | after 4 cycles(each cycle is 28 days) of chemotherapy |
| Lyon |
| 69004 |
| France |
| Centre Léon Bérard | Lyon | 69008 | France |