Hematologic CancerCANUT-QVANCT04235153
CAncer, NUtrition and Taste - Validation of the CANUT-QVA Questionnaire on Eating Habits in Cancer Patients
An observational study of Hematologic Cancer and Undernutrition, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Cancer, Undernutrition, Chemotherapy Effect
- What is being tested?
- Evaluation of the 9 dimensions of the CANUT-QVA questionnaire
- How many people
- 127 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jan 2020to 12 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with solid or hematological cancer complete the CANUT-QVA questionnaire.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Hospices Civils de Lyon, Groupement Hospitalier Lyon Sud, Service pneumologie
Pierre-Bénite, 69310
About this study
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.
Read more
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.
- Conditions
- Hematologic Cancer, Undernutrition, Chemotherapy Effect, Taste Disorders, Chemotherapy-Induced Change, Olfactory Disorder
- Being tested
- Evaluation of the 9 dimensions of the CANUT-QVA questionnaire
- Medical subject headings
- Hematologic Neoplasms, Malnutrition, Taste Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of the 9 dimensions of the CANUT-QVA questionnaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with solid or hematological cancer | All the patients complete the CANUT-QVA questionnaire Receives: Other: Evaluation of the 9 dimensions of the CANUT-QVA questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start9 Jan 2020
- Primary completion12 Mar 2020
- Study completion12 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic CancerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04235153
- Sponsor's protocol ID
- 69HCL19_0617
- Acronym
- CANUT-QVA
- Status last verified
- Jul 2021
- First submitted
- 16 Jan 2020
- Last updated
- 9 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAncer, NUtrition and Taste - Validation of the CANUT-QVA Questionnaire on Eating Habits in Cancer Patients
- ClinicalTrials.gov ID
- NCT04235153
- Acronym / sponsor ID
- CANUT-QVA / 69HCL19_0617
- Conditions
- Hematologic Cancer, Undernutrition, Chemotherapy Effect, Taste Disorders, Chemotherapy-Induced Change, Olfactory Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- 12 Mar 2020 (actual)
- Study completion
- 12 Mar 2020 (actual)
- First posted
- 21 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with solid or hematological cancer | – | Other: Evaluation of the 9 dimensions of the CANUT-QVA questionnaireAll the patients complete the CANUT-QVA questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with solid or hematological cancer complete the CANUT-QVA questionnaire.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of the 9 dimensions of the CANUT-QVA questionnaireEvaluation 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. | Other | Patients with solid or hematological cancer |
Primary outcome
Validate the 9 dimensions of the CANUT-QVA questionnaire identified during the general population analysis.
Time frame: day 0
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematologic Cancer and Undernutrition, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validate the 9 dimensions of the CANUT-QVA questionnaire identified during the general population analysis. (time frame: day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2021.