NCT07490093

Brief 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. 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.

Trial Health

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Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
4mo left

Started Feb 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress46%
Feb 2026Oct 2026

Study Start

First participant enrolled

February 1, 2026

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 24, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

8 months

First QC Date

February 9, 2026

Last Update Submit

March 19, 2026

Conditions

Keywords

chemotherapyoncologychildrentaste alterationssmell disordereating behaviour changescoping strategies

Outcome Measures

Primary Outcomes (1)

  • 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

    at least 2 months after the beginning of the chemotherapy

Secondary Outcomes (7)

  • Determine the effectiveness and purpose of these strategies.

    at least 2 months after the beginning of the chemotherapy

  • Characterize the sensory alterations reported by children undergoing chemotherapy

    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.

    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

    at least 2 months after the beginning of the chemotherapy

  • Study the impact of treatment type and stage on food perception and eating behavior.

    at least 2 months after the beginning of the chemotherapy

  • +2 more secondary outcomes

Study Arms (2)

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

Interventions

no intervention

children aged 6-17 years undergoing chemotherapy for a malignant hematological or solid tumorone of the parent of the children included in the first group

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut d'Hématologie et d'Oncologie Pédiatrique

Lyon, 69008, France

Location

MeSH Terms

Conditions

Olfaction DisordersNeoplasms

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Anestis Dougkas

    Institut Lyfe

    STUDY DIRECTOR

Central Study Contacts

Séverine Bouttefroy

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2026

First Posted

March 24, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

March 24, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations