NCT04235153

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
127

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 9, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 21, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2020

Completed
Last Updated

July 9, 2021

Status Verified

July 1, 2021

Enrollment Period

2 months

First QC Date

January 16, 2020

Last Update Submit

July 6, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Patients with solid or hematological cancer

All the patients complete the CANUT-QVA questionnaire

Other: Evaluation of the 9 dimensions of the CANUT-QVA questionnaire

Interventions

Evaluation of the contribution of a new questionnaire by patients with solid or hematological cancer according to 9 dimensions: 1. Making food 2. Place where the meals are eaten 3. Eating and drinking: Nutrition 4. Eating and drinking: The pleasure of tasting, chewing 5. Eating and drinking: Satiated, well being 6. Food preparation: Supply, choice, presentation 7. Eating and drinking: Feelings 8. After eating: heaviness, discomfort, hunger 9. Taste/Odour Problems to confirm the number and structure of factors obtained at the end of the pre-study and to remove redundant questions.

Patients with solid or hematological cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with solid or hematological cancer complete the CANUT-QVA questionnaire.

You may qualify if:

  • Patient who does not object to participate in the trial
  • Patient affiliated to a social security system

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon, Groupement Hospitalier Lyon Sud, Service pneumologie

Pierre-Bénite, 69310, France

Location

MeSH Terms

Conditions

Hematologic NeoplasmsMalnutritionTaste Disorders

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesNutrition DisordersNutritional and Metabolic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2020

First Posted

January 21, 2020

Study Start

January 9, 2020

Primary Completion

March 12, 2020

Study Completion

March 12, 2020

Last Updated

July 9, 2021

Record last verified: 2021-07

Locations