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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04235153
Other study ID # 69HCL19_0617
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 9, 2020
Est. completion date March 12, 2020

Study information

Verified date July 2021
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Cancer patients are at high risk of undernutrition, which is generally more pronounced for solid tumours (upper digestive tract, Ear Nose and Throat (ENT), bronchial tubes). This undernutrition leads to major weight loss and cachexia, and may represent the first sign of a call for a diagnosis of cancer. Cancer-related undernutrition is multi-factorial origins and has multiple consequences. 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. The alteration of 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 treated with chemotherapy. The assessment of taste disorders in patients treated with chemotherapy 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 treated with chemotherapy. As regards food products, patients report developing olfactory hypersensitivity mainly for food of animal origin, in particular for odours of fish, frying, cheese and eggs. The CANUT project aims 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 order to monitor the evolution of patients' eating habits over time, the diet-related quality of life questionnaire (CANUT-QVA) was constructed from items selected from the Well-being related to Food questionnaire (WELLBFQ) after eliminating questions that were too general or expressed in terms of importance to use perception-related responses as a priority. After this part, an evaluation of the 9 dimensions of the CANUT-QVA questionnaire will be performed.


Recruitment information / eligibility

Status Completed
Enrollment 127
Est. completion date March 12, 2020
Est. primary completion date March 12, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient with solid or hematological cancer (any stage of disease and any treatment) diagnosed within 12 months of inclusion. - Patient who does not object to participate in the trial - Patient affiliated to a social security system Exclusion Criteria: - Minor patient (age <18 years). - Patient under trusteeship, curatorship or protective measures. - Patient who has already completed the questionnaire. - Patient not sufficiently able to speak French to answer the questionnaire

Study Design


Intervention

Other:
Evaluation of the 9 dimensions of the CANUT-QVA questionnaire
Evaluation of the contribution of a new questionnaire by patients with solid or hematological cancer according to 9 dimensions: Making food Place where the meals are eaten Eating and drinking: Nutrition Eating and drinking: The pleasure of tasting, chewing Eating and drinking: Satiated, well being Food preparation: Supply, choice, presentation Eating and drinking: Feelings After eating: heaviness, discomfort, hunger Taste/Odour Problems to confirm the number and structure of factors obtained at the end of the pre-study and to remove redundant questions.

Locations

Country Name City State
France Hospices Civils de Lyon, Groupement Hospitalier Lyon Sud, Service pneumologie Pierre-Bénite

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 Validate the 9 dimensions of the CANUT-QVA questionnaire identified during the general population analysis. The main evaluation criterion will be the adequacy between the responses to the food quality of life questionnaire by patients and the structure of the 9 dimensions as presented in the context (relevance of the questions for each dimension). day 0
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