NCT07437326

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
14mo left

Started Mar 2026

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
Mar 2026Sep 2027

First Submitted

Initial submission to the registry

February 20, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

1.5 years

First QC Date

February 20, 2026

Last Update Submit

February 20, 2026

Conditions

Keywords

cancerfoodnutritionperceptionsquality of life related to food

Outcome Measures

Primary Outcomes (1)

  • 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.

    day of inclusion

Study Arms (2)

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.

Other: Self-reported questionnairesOther: 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.

Other: Self-reported questionnairesOther: Salivary and sensory tests

Interventions

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.

Patients after treatmentPatients under treatment

Objective tests will be performed to measure the salivary quality and quantity and taste and smell perceptions.

Patients after treatmentPatients under treatment

Eligibility Criteria

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

You may qualify if:

  • 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;
  • Patient capable of filling a questionnaire;
  • Patient having given his free, informed and express consent.

You may not qualify if:

  • \- 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hôpital Femme Mère Enfant

Bron, France

Location

Hôpital de la Croix Rousse

Lyon, France

Location

Hôpital Lyon Sud

Oullins, France

Location

MeSH Terms

Conditions

Breast NeoplasmsHead and Neck NeoplasmsGastrointestinal NeoplasmsLung NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Amandine BRUYAS, Dr

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amandine BRUYAS, Dr

CONTACT

Irina Elena ANTOCHI

CONTACT

Study Design

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

Study Record Dates

First Submitted

February 20, 2026

First Posted

February 27, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations