Taste AlterationsQUALISENSNCT07490093
Adaptation Strategies for Coping With the Impact of Sensory Alterations on Eating Behavior in Children With Cancer: A Qualitative Study From the Perspective of Children and Parents
An observational study of Taste Alterations and Smell Disorder, run by Centre Leon Berard at 1 site in France.
Trial summary
Childhood cancer is a serious and life-changing disease that affects thousands of children every year worldwide. In addition to the disease itself, cancer treatments such as chemotherapy often cause difficult side effects. Among these, changes in taste and smell are very common but still poorly understood in children. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Taste Alterations, Smell Disorder, Eating Behavior Changes
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2026to Oct 2026
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: History of cancer Any cognitive impairment or condition that may limit the use of numerical scales and quality of life questionnaires, including but not limited to: Children with neurodevelopmental disorders such as autism or Down syndrome These children may have specific cognitive or communication characteristics that require specialized interview techniques. Their inclusion could complicate data comparability and introduce confounding factors. This exclusion ensures data quality and consistency, while respecting the well-being of participants. Patients for whom other types of cancer treatment are planned during the study period (e.g., radiation therapy) Patients in relapse Presence of a pre-existing pediatric eating disorder or pre-existing food selectivity
Who may be able to join
- Children:
- Aged 6 to 17 years old on the day consent is obtained.
- Diagnosed with a malignant hematological or oncological tumor.
- Possessing sufficient verbal ability to participate in the interview planned for the study.
- Having started chemotherapy treatment at least 2 months prior.
- Agreeing to participate in the study.
Show all 12Show fewer
- Able to understand, read, and write French.
- Affiliated with a social security system.
- Parents:
- Be the parent or legal guardian of a child aged 6 to 17 inclusive, with cancer and undergoing chemotherapy.
- Dated and signed informed consent.
- Able to understand, read, and write French.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Séverine Bouttefroy contact
About this study
Childhood cancer is a serious and life-changing disease that affects thousands of children every year worldwide. In addition to the disease itself, cancer treatments such as chemotherapy often cause difficult side effects. Among these, changes in taste and smell are very common but still poorly understood in children. These sensory changes can make food taste unpleasant or smell different, leading children to eat less, avoid certain foods, or develop strong food aversions. As a result, many children with cancer experience weight loss, poor nutrition, and reduced quality of life, which can also affect how well they tolerate treatment.
Research suggests that between 40% and 60% of children with cancer struggle to maintain good nutritional status during treatment. Taste and smell alterations play a major role in these difficulties. Children may experience nausea triggered by food smells, changes in food texture perception, or a loss of pleasure in eating. Parents often report feeling powerless and lacking clear guidance on how to help their child cope with these problems.
Read more
While taste and smell disturbances have been widely studied in adults with cancer, much less is known about how children experience these changes and, importantly, how they and their families adapt to them. Parents play a key role in supporting their child's eating habits, but their perspectives may differ from the child's own experiences.
This study aims to better understand how children undergoing chemotherapy and their parents perceive changes in taste, smell, and food texture, and how these changes affect eating behavior, emotions, and social life. Using individual semi-structured interviews, the study will explore the coping strategies used by children and parents to manage these sensory changes, both at home and in the hospital setting.
By giving children and parents a voice, this research seeks to identify practical, real-life strategies that families find helpful. The results will contribute to improving nutritional support and guidance for children with cancer, with the ultimate goal of enhancing their well-being, quality of life, and treatment outcomes.
Read the detailed description
Childhood cancer represents a major public health concern and remains one of the leading causes of disease-related mortality in children. Advances in treatment have improved survival, but chemotherapy is frequently associated with adverse effects that significantly impact nutritional status and quality of life. Malnutrition affects approximately 40-60% of pediatric oncology patients and is associated with poorer treatment tolerance, increased risk of infection, immune dysfunction, and reduced survival.
Among treatment-related toxicities, alterations in taste (dysgeusia) and smell (dysosmia) are increasingly recognized as key contributors to feeding difficulties. Chemotherapy targets rapidly dividing cells, including gustatory and olfactory receptor cells, which may explain the high prevalence of sensory disturbances. Taste and smell play a central role in appetite regulation and food enjoyment; their disruption can lead to reduced intake, food aversions, and changes in texture preferences. Although these effects are well documented in adults, pediatric data remain limited and heterogeneous, particularly regarding children's subjective experiences and coping mechanisms.
Recent studies suggest that up to 60% of children receiving chemotherapy experience taste and/or smell alterations perceived as highly distressing. Adolescents frequently report that food "does not taste good" and that food-related smells trigger nausea. Parents often identify sensory changes as the main cause of feeding problems, yet discrepancies may exist between parental perceptions and children's lived experiences. Furthermore, little is known about how food texture perception evolves in children with cancer, despite evidence that tactile oral sensitivity can strongly influence food selectivity.
This study is designed as a prospective, monocentric, non-interventional observational study (RIPH3), using a qualitative methodology based on individual semi-structured interviews. Participants will include children aged 6-17 years undergoing chemotherapy for a malignant hematological or solid tumor, and one of their parents or legal guardians. Interviews will be conducted separately with children and parents to ensure independent data collection and minimize mutual influence. Fifteen children and one of their parent will be included.
The primary objective is to identify and describe the coping strategies used by children and parents to manage taste, smell, and texture alterations and associated changes in eating behavior during chemotherapy. Secondary objectives include characterizing the nature, frequency, intensity, and duration of reported sensory alterations; exploring their emotional and social impact; examining the influence of cancer type, treatment stage, and eating context (hospital versus home); and assessing concordance and discrepancies between children's and parents' experiences and descriptions.
Data analysis will follow a rigorous qualitative approach, including thematic coding, verification of code saturation, and cross-checking by a second researcher to ensure analytical reliability. Reflexivity will be supported through the use of a field journal documenting the researcher's observations and potential biases.
This study will be among the first qualitative investigations in France to focus specifically on chemo-sensory alterations in pediatric oncology from both the child's and the parent's perspectives. By identifying effective, family-driven coping strategies, the findings aim to inform future nutritional guidance, supportive care interventions, and clinical recommendations, ultimately improving nutritional outcomes and quality of life for children undergoing cancer treatment.
- Conditions
- Taste Alterations, Smell Disorder, Eating Behavior Changes
- Being tested
- No Intervention: Observational Cohort
- Keywords
- chemotherapy, oncology, children, taste alterations, smell disorder, eating behaviour changes, coping strategies
- Medical subject headings
- Olfaction Disorders, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortBehavioural
no intervention
| Study group | Role | What they receive |
|---|---|---|
| children aged 6-17 years undergoing chemotherapy for a malignant hematological or solid tumor | Not described Receives: Behavioral: No Intervention: Observational Cohort | |
| one of the parent of the children included in the first group | Not described Receives: Behavioral: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
coping strategies of the children and their parents for managment of sensory alterations and eating behaviour
Determine the coping strategies used by children and their parents to manage sensory alterations and eating behavior during chemotherapy.
the method for the thematic analysis of qualitative data described by Braun and Clarke will be used
Measured: at least 2 months after the beginning of the chemotherapy
Secondary outcomes (7)
Determine the effectiveness and purpose of these strategies.
the method for the thematic analysis of qualitative data described by Braun and Clarke will be used
Measured: at least 2 months after the beginning of the chemotherapy
Characterize the sensory alterations reported by children undergoing chemotherapy
the method for the thematic analysis of qualitative data described by Braun and Clarke will be used
Measured: at least 2 months after the beginning of the chemotherapy
Identify the frequency, reported intensity, and duration of alterations in taste, smell, and texture, and their role in eating behavior in children undergoing chemotherapy.
the method for the thematic analysis of qualitative data described by Braun and Clarke will be used
Measured: at least 2 months after the beginning of the chemotherapy
Determine the influence of cancer type and eating environment (hospital or home) on food perception
the method for the thematic analysis of qualitative data described by Braun and Clarke will be used
Measured: at least 2 months after the beginning of the chemotherapy
Study the impact of treatment type and stage on food perception and eating behavior.
the method for the thematic analysis of qualitative data described by Braun and Clarke will be used
Measured: at least 2 months after the beginning of the chemotherapy
Assess the role of sensory alterations on children's quality of life, particularly their emotional and social well-being.
the method for the thematic analysis of qualitative data described by Braun and Clarke will be used
Measured: at least 2 months after the beginning of the chemotherapy
Determine the relationship between the experiences of children and their parents by identifying their awareness of problems and their ability to describe them accurately.
the method for the thematic analysis of qualitative data described by Braun and Clarke will be used
Measured: at least 2 months after the beginning of the chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study startFeb 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Taste AlterationsStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe 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
- Case only
- Time perspective
- Other
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Collaborators
- Nutricia, Inc.
- Responsible party
- Sponsor
- Investigators
- Anestis Dougkas, Study director, Institut Lyfe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07490093
- Sponsor's protocol ID
- ET25-318
- Acronym
- QUALISENS
- Status last verified
- Mar 2026
- First submitted
- 9 Feb 2026
- Last updated
- 24 Mar 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 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation Strategies for Coping With the Impact of Sensory Alterations on Eating Behavior in Children With Cancer: A Qualitative Study From the Perspective of Children and Parents
- ClinicalTrials.gov ID
- NCT07490093
- Acronym / sponsor ID
- QUALISENS / ET25-318
- Conditions
- Taste Alterations, Smell Disorder, Eating Behavior Changes
- Keywords
- chemotherapy, oncology, children, taste alterations, smell disorder, eating behaviour changes, coping strategies
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Collaborators
- Nutricia, Inc.
- Study start
- Feb 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 24 Mar 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.
Childhood cancer is a serious and life-changing disease that affects thousands of children every year worldwide. In addition to the disease itself, cancer treatments such as chemotherapy often cause difficult side effects. Among these, changes in taste and smell are very common but still poorly understood in children. These sensory changes can make food taste unpleasant or smell different, leading children to eat less, avoid certain foods, or develop strong food aversions. As a result, many children with cancer experience weight loss, poor nutrition, and reduced quality of life, which can also affect how well they tolerate treatment.
Research suggests that between 40% and 60% of children with cancer struggle to maintain good nutritional status during treatment. Taste and smell alterations play a major role in these difficulties. Children may experience nausea triggered by food smells, changes in food texture perception, or a loss of pleasure in eating. Parents often report feeling powerless and lacking clear guidance on how to help their child cope with these problems.
While taste and smell disturbances have been widely studied in adults with cancer, much less is known about how children experience these changes and, importantly, how they and their families adapt to them. Parents play a key role in supporting their child's eating habits, but their perspectives may differ from the child's own experiences.
This study aims to better understand how children undergoing chemotherapy and their parents perceive changes in taste, smell, and food texture, and how these changes affect eating behavior, emotions, and social life. Using individual semi-structured interviews, the study will explore the coping strategies used by children and parents to manage these sensory changes, both at home and in the hospital setting.
By giving children and parents a voice, this research seeks to identify practical, real-life strategies that families find helpful. The results will contribute to improving nutritional support and guidance for children with cancer, with the ultimate goal of enhancing their well-being, quality of life, and treatment outcomes.
Detailed description
Childhood cancer represents a major public health concern and remains one of the leading causes of disease-related mortality in children. Advances in treatment have improved survival, but chemotherapy is frequently associated with adverse effects that significantly impact nutritional status and quality of life. Malnutrition affects approximately 40-60% of pediatric oncology patients and is associated with poorer treatment tolerance, increased risk of infection, immune dysfunction, and reduced survival.
Among treatment-related toxicities, alterations in taste (dysgeusia) and smell (dysosmia) are increasingly recognized as key contributors to feeding difficulties. Chemotherapy targets rapidly dividing cells, including gustatory and olfactory receptor cells, which may explain the high prevalence of sensory disturbances. Taste and smell play a central role in appetite regulation and food enjoyment; their disruption can lead to reduced intake, food aversions, and changes in texture preferences. Although these effects are well documented in adults, pediatric data remain limited and heterogeneous, particularly regarding children's subjective experiences and coping mechanisms.
Recent studies suggest that up to 60% of children receiving chemotherapy experience taste and/or smell alterations perceived as highly distressing. Adolescents frequently report that food "does not taste good" and that food-related smells trigger nausea. Parents often identify sensory changes as the main cause of feeding problems, yet discrepancies may exist between parental perceptions and children's lived experiences. Furthermore, little is known about how food texture perception evolves in children with cancer, despite evidence that tactile oral sensitivity can strongly influence food selectivity.
This study is designed as a prospective, monocentric, non-interventional observational study (RIPH3), using a qualitative methodology based on individual semi-structured interviews. Participants will include children aged 6-17 years undergoing chemotherapy for a malignant hematological or solid tumor, and one of their parents or legal guardians. Interviews will be conducted separately with children and parents to ensure independent data collection and minimize mutual influence. Fifteen children and one of their parent will be included.
The primary objective is to identify and describe the coping strategies used by children and parents to manage taste, smell, and texture alterations and associated changes in eating behavior during chemotherapy. Secondary objectives include characterizing the nature, frequency, intensity, and duration of reported sensory alterations; exploring their emotional and social impact; examining the influence of cancer type, treatment stage, and eating context (hospital versus home); and assessing concordance and discrepancies between children's and parents' experiences and descriptions.
Data analysis will follow a rigorous qualitative approach, including thematic coding, verification of code saturation, and cross-checking by a second researcher to ensure analytical reliability. Reflexivity will be supported through the use of a field journal documenting the researcher's observations and potential biases.
This study will be among the first qualitative investigations in France to focus specifically on chemo-sensory alterations in pediatric oncology from both the child's and the parent's perspectives. By identifying effective, family-driven coping strategies, the findings aim to inform future nutritional guidance, supportive care interventions, and clinical recommendations, ultimately improving nutritional outcomes and quality of life for children undergoing cancer treatment.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| children aged 6-17 years undergoing chemotherapy for a malignant hematological or solid tumor | – | Behavioral: No Intervention: Observational Cohort |
| one of the parent of the children included in the first group | – | Behavioral: No Intervention: Observational Cohort |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- History of cancer Any cognitive impairment or condition that may limit the use of numerical scales and quality of life questionnaires, including but not limited to: Children with neurodevelopmental disorders such as autism or Down syndrome These children may have specific cognitive or communication characteristics that require specialized interview techniques. Their inclusion could complicate data comparability and introduce confounding factors. This exclusion ensures data quality and consistency, while respecting the well-being of participants. Patients for whom other types of cancer treatment are planned during the study period (e.g., radiation therapy) Patients in relapse Presence of a pre-existing pediatric eating disorder or pre-existing food selectivity
Key inclusion criteria (12 listed)
- Aged 6 to 17 years old on the day consent is obtained.
- Diagnosed with a malignant hematological or oncological tumor.
- Possessing sufficient verbal ability to participate in the interview planned for the study.
- Having started chemotherapy treatment at least 2 months prior.
- Agreeing to participate in the study.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| No Intervention: Observational Cohortno intervention | Behavioural | children aged 6-17 years undergoing chemotherapy for a malignant hematological or solid tumor, one of the parent of the children included in the first group |
Primary outcome
coping strategies of the children and their parents for managment of sensory alterations and eating behaviour
Time frame: at least 2 months after the beginning of the chemotherapy
Determine the coping strategies used by children and their parents to manage sensory alterations and eating behavior during chemotherapy. the method for the thematic analysis of qualitative data described by Braun and Clarke will be used
7 secondary outcomes
Determine the effectiveness and purpose of these strategies.
Time frame: at least 2 months after the beginning of the chemotherapy
Characterize the sensory alterations reported by children undergoing chemotherapy
Time frame: at least 2 months after the beginning of the chemotherapy
Identify the frequency, reported intensity, and duration of alterations in taste, smell, and texture, and their role in eating behavior in children undergoing chemotherapy.
Time frame: at least 2 months after the beginning of the chemotherapy
Determine the influence of cancer type and eating environment (hospital or home) on food perception
Time frame: at least 2 months after the beginning of the chemotherapy
Study the impact of treatment type and stage on food perception and eating behavior.
Time frame: at least 2 months after the beginning of the chemotherapy
Assess the role of sensory alterations on children's quality of life, particularly their emotional and social well-being.
Time frame: at least 2 months after the beginning of the chemotherapy
Determine the relationship between the experiences of children and their parents by identifying their awareness of problems and their ability to describe them accurately.
Time frame: at least 2 months after the beginning of the chemotherapy
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 24 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Taste Alterations
Recruiting
Nurse-Led Self-Management Program on Taste Alteration in Women With Breast Cancer
Chemotherapy-Related Taste Alteration
RecruitingObservational study
Changes in Taste and Eating Habits Associated With GLP-1 Agonists in Weight Loss Patients
Obesity & Overweight, Taste Alterations
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.
Séverine Bouttefroy contact
Anestis Dougkas study director
Institut Lyfe
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 Taste Alterations and Smell Disorder, run by Centre Leon Berard 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 12 inclusion and 1 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 24 Mar 2026. 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?
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 Samia Saraya (+33767889375, ssaraya-jean@institutlyfe.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
coping strategies of the children and their parents for managment of sensory alterations and eating behaviour (time frame: at least 2 months after the beginning of the chemotherapy). 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 24 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.