Breast CancerQVA-ModNCT07437326
Food-related Quality of Life in Patients With Cancer
An observational study of Breast Cancer and Head and Neck Cancers, run by Hospices Civils de Lyon at 3 sites in France.
Trial summary
Food plays a fundamental role in quality of life. In patients with cancer psychological burden and treatment-related side effects can impact appetite, taste perception and pleasure of eating, making nutritional management more challenging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Head and Neck Cancers, Gynecologic Cancer
- What is being tested?
- Self-reported questionnaires and Salivary and sensory tests
- Type of treatment
- Pill or oral medicine
- How many people
- 180 participants
- Where
- 3 sitesFrance
- Study dates
- Mar 2026to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 different types of cancer gastrointestinal, breast, gynecologic, head and neck, lung, aged between 18 years or older. Two cohorts are considered: patients under treatment (chemotherapy, targeted therapy, immunotherapy, etc., except patients undergoing head and neck radiotherapy) from at least two months and patients having undergone anticancer treatment having completed it at least 3 months and no more than 12 months before inclusion. The necessary number of patients is 180, 90 patients in each cohort.
Who may be able to join
- Patient aged 18 years or older;
- Patient with gastrointestinal, breast, gynecologic, head and neck, lung
- Patient receiving a cancer treatment (chemotherapy, targeted therapy, immunotherapy, etc.) from at least two months;
- Patients having undergone anticancer treatment (chemotherapy, targeted therapy, immunotherapy, etc.) having completed it at least 3 months and no more than 12 months before inclusion;
- Patient capable of filling a questionnaire;
- Patient having given his free, informed and express consent.
Who cannot join
- - Patient having a radiotherapy treatment for a head or neck cancer;
- Patient having presented nausea and vomiting during the last 24 hours;
- Patient with severe inflammation of the mouth or throat (ulcers, mucus);
- Patient with cognitive disorders and memory loss;
- Pregnant women or breastfeeding;
- Adult under legal protection (guardianship, curatorship).
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Irina Elena ANTOCHI contact
France3 sites
Hôpital Femme Mère Enfant
Bron
Marie BEGUINOT, Dr, marie.beguinot-cornillon@chu-lyon.fr
Hôpital de la Croix Rousse
Lyon
Amandine BRUYAS, Dr, 478861628 ext. +33, amandine.bruyas@chu-lyon.fr
Hôpital Lyon Sud
Oullins
Benoit YOU, Pr, benoit.you@chu-lyon.fr
About this study
Official title: Modeling the Influence of Pathological Factors, Oral Symptoms and Sensory Perception on Food-related Quality of Life in Patients With Cancer
Food plays a fundamental role in quality of life. In patients with cancer psychological burden and treatment-related side effects can impact appetite, taste perception and pleasure of eating, making nutritional management more challenging.
Given the central role of food and nutrition in maintaining physical health and psychological well-being, it is essential to better understand the factors that contribute to food-related quality of life in order to improve the quality of life of patients with cancer. Despite the importance of these psychological aspects, current assessments tools do not adequately measure the impact of cancer on the food-related quality of life.
Read more
In a study entitled "CANUT-QVA" a specific questionnaire measuring nine dimensions of food related quality of life was developed, allowing for a better understanding of how patients perceive and experience their diet. This instrument consists of 46 items and explores nine dimensions, its use showing a significant decrease in food related quality of life of patients with breast cancer, opening the way for targeted interventions to improve nutritional well being and overall quality of life in cancer patients.
The present study aims to analyse various factors - such as oral health, sensory profile and clinical characteristics - associated with food-related quality of life in patients with cancer (gastrointestinal, head and neck, lung, breast and gynecologic cancer) during or after treatment, in order to develop a predictive model of food related quality of life. The main objective of this project is to identify the population at highest risk, so as to better tailor nutritional interventions for patients with cancer, considering both the type of treatment received and the phase, during or after treatment. The food-related quality of life questionnaire containing 46 items will be used to measure the primary outcome.
- Conditions
- Breast Cancer, Head and Neck Cancers, Gynecologic Cancer, Gastrointestinal Cancer, Lung Cancer
- Being tested
- Self-reported questionnaires, Salivary and sensory tests
- Keywords
- cancer, food, nutrition, perceptions, quality of life related to food
- Medical subject headings
- Breast Neoplasms, Head and Neck Neoplasms, Gastrointestinal Neoplasms, Lung Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-reported questionnairesOther
Self-reported questionnaires will be used to asses patient's food-related quality of life (QVA questionnaire), global quality of life (EORTC QLQ-C30 questionnaire), evaluation of oral symptoms and perceptions.
Salivary and sensory testsOther
Objective tests will be performed to measure the salivary quality and quantity and taste and smell perceptions.
| Study group | Role | What they receive |
|---|---|---|
| Patients under treatment | Patients with cancer (gastrointestinal, breast, head and neck, gynecologic, lung), under treatment from at least two months, receiving active anticancer treatment (chemotherapy, targeted therapy, immunotherapy, etc., except patients undergoing head and neck radiotherapy) in a standard of care program. Receives: Other: Self-reported questionnaires; Other: Salivary and sensory tests | |
| Patients after treatment | Patients who have undergone anticancer treatment (chemotherapy, targeted therapy, immunotherapy, etc.) having completed it at least 3 months and no more then 12 months before inclusion. Receives: Other: Self-reported questionnaires; Other: Salivary and sensory tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
The food-related quality of life in patients with cancer (gastrointestinal, breast, head and neck, gynecologic, lung).
The food-related quality of life questionnaire containing 46 items will be used to measure the outcome. The questionnaire uses a Likert scale: 1 = never; 2 = sometimes; 3 = often; 4 = always.
Measured: day of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study startMar 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast 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
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amandine BRUYAS, Dr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07437326
- Sponsor's protocol ID
- 69HCL25_0908
- Other IDs
- 2025-A02292-47
- Acronym
- QVA-Mod
- Status last verified
- Feb 2026
- First submitted
- 20 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modeling the Influence of Pathological Factors, Oral Symptoms and Sensory Perception on Food-related Quality of Life in Patients With Cancer
- ClinicalTrials.gov ID
- NCT07437326
- Acronym / sponsor ID
- QVA-Mod / 69HCL25_0908
- Conditions
- Breast Cancer, Head and Neck Cancers, Gynecologic Cancer, Gastrointestinal Cancer, Lung Cancer
- Keywords
- cancer, food, nutrition, perceptions, quality of life related to food
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 27 Feb 2026 (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.
Food plays a fundamental role in quality of life. In patients with cancer psychological burden and treatment-related side effects can impact appetite, taste perception and pleasure of eating, making nutritional management more challenging.
Given the central role of food and nutrition in maintaining physical health and psychological well-being, it is essential to better understand the factors that contribute to food-related quality of life in order to improve the quality of life of patients with cancer. Despite the importance of these psychological aspects, current assessments tools do not adequately measure the impact of cancer on the food-related quality of life.
In a study entitled "CANUT-QVA" a specific questionnaire measuring nine dimensions of food related quality of life was developed, allowing for a better understanding of how patients perceive and experience their diet. This instrument consists of 46 items and explores nine dimensions, its use showing a significant decrease in food related quality of life of patients with breast cancer, opening the way for targeted interventions to improve nutritional well being and overall quality of life in cancer patients.
The present study aims to analyse various factors - such as oral health, sensory profile and clinical characteristics - associated with food-related quality of life in patients with cancer (gastrointestinal, head and neck, lung, breast and gynecologic cancer) during or after treatment, in order to develop a predictive model of food related quality of life. The main objective of this project is to identify the population at highest risk, so as to better tailor nutritional interventions for patients with cancer, considering both the type of treatment received and the phase, during or after treatment. The food-related quality of life questionnaire containing 46 items will be used to measure the primary outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients under treatment | – | Other: Self-reported questionnaires, Other: Salivary and sensory testsPatients with cancer (gastrointestinal, breast, head and neck, gynecologic, lung), under treatment from at least two months, receiving active anticancer treatment (chemotherapy, targeted therapy, immunotherapy, etc., except patients undergoing head and neck radiotherapy) in a standard of care program. |
| Patients after treatment | – | Other: Self-reported questionnaires, Other: Salivary and sensory testsPatients who have undergone anticancer treatment (chemotherapy, targeted therapy, immunotherapy, etc.) having completed it at least 3 months and no more then 12 months before inclusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with different types of cancer gastrointestinal, breast, gynecologic, head and neck, lung, aged between 18 years or older. Two cohorts are considered: patients under treatment (chemotherapy, targeted therapy, immunotherapy, etc., except patients undergoing head and neck radiotherapy) from at least two months and patients having undergone anticancer treatment having completed it at least 3 months and no more than 12 months before inclusion. The necessary number of patients is 180, 90 patients in each cohort.
Key inclusion criteria (6 listed)
- Patient aged 18 years or older;
- Patient with gastrointestinal, breast, gynecologic, head and neck, lung
- Patient receiving a cancer treatment (chemotherapy, targeted therapy, immunotherapy, etc.) from at least two months;
- Patients having undergone anticancer treatment (chemotherapy, targeted therapy, immunotherapy, etc.) having completed it at least 3 months and no more than 12 months before inclusion;
- Patient capable of filling a questionnaire;
Key exclusion criteria (6 listed)
- - Patient having a radiotherapy treatment for a head or neck cancer;
- Patient having presented nausea and vomiting during the last 24 hours;
- Patient with severe inflammation of the mouth or throat (ulcers, mucus);
- Patient with cognitive disorders and memory loss;
- Pregnant women or breastfeeding;
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 |
|---|---|---|
| Self-reported questionnairesSelf-reported questionnaires will be used to asses patient's food-related quality of life (QVA questionnaire), global quality of life (EORTC QLQ-C30 questionnaire), evaluation of oral symptoms and perceptions. | Other | Patients after treatment, Patients under treatment |
| Salivary and sensory testsObjective tests will be performed to measure the salivary quality and quantity and taste and smell perceptions. | Other | Patients after treatment, Patients under treatment |
Primary outcome
The food-related quality of life in patients with cancer (gastrointestinal, breast, head and neck, gynecologic, lung).
Time frame: day of inclusion
The food-related quality of life questionnaire containing 46 items will be used to measure the outcome. The questionnaire uses a Likert scale: 1 = never; 2 = sometimes; 3 = often; 4 = always.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Irina Elena ANTOCHI contact
Amandine BRUYAS, Dr principal investigator
Hospices Civils de Lyon
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Head and Neck Cancers, run by Hospices Civils de Lyon at 3 sites 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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amandine BRUYAS, Dr (478861628 ext. +33, amandine.bruyas@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The food-related quality of life in patients with cancer (gastrointestinal, breast, head and neck, gynecologic, lung). (time frame: day of inclusion). 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 27 Feb 2026.