NCT06643026

Brief Summary

Nutritional status is a major issue in the management of cancer patients. Forty to 60% of patients are undernourished at diagnosis. This undernutrition has a direct impact on patients' health and quality of life, with a reduction in survival associated with an increase in the risk of toxicity from anti-cancer treatments (chemotherapy, radiotherapy, surgery), the risk of infection and the risk of hospitalization. Thus, it is estimated that 10-20% of cancer patients die from the consequences of their undernutrition rather than from the tumor itself (Muscaritoli et al. 2021). It is therefore recommended to systematically implement a multimodal nutritional intervention in cancer patients (recommendations of the learned societies ESPEN, ESMO and ASCO), combining nutritional support (oral and/or enteral and/or parenteral) with physical exercise (Muscaritoli et al. 2021). However, despite the systematic provision of dietary management, the effectiveness of nutritional interventions varies from patient to patient in terms of nutritional status, quality of life and overall survival (Cintoni et al. 2023). Among the factors impacting patient compliance with dietary measures and their efficacy, sensory alterations occurring under chemotherapy potentially have a major impact (Drareni et al., 2019). Indeed, the vast majority of patients describe an alteration in tastes and smells after starting chemotherapy treatment. However, few studies have focused on the specific parameters associated with these alterations. The aim of this study is to prospectively assess changes in sensory perceptions and eating habits in patients undergoing chemotherapy for digestive cancer at the start of treatment and after the first cycle of chemotherapy, and to correlate these alterations with patients' nutritional profile and clinical course.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

3 active sites

Status
completed

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

First Submitted

Initial submission to the registry

October 14, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

November 22, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2026

Completed
Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

1.1 years

First QC Date

October 14, 2024

Last Update Submit

March 13, 2026

Conditions

Keywords

digestive cancerschemotherapyfood preferencesensory perceptions

Outcome Measures

Primary Outcomes (1)

  • Proportion of patient with changes in food preferences of digestive cancer patients at the end of the first cycle of chemotherapy.

    Proportion of patients with 'altered' food preferences at the end of the first cycle of chemotherapy, with alteration defined as a reported decrease in appreciation for at least 30% of foods compared to before chemotherapy initiation

    At two month (end of the first cycle of chemotherapy/immunotherapy)

Study Arms (2)

Patients with digestive cancer traited by chemotherapy

Patients with malignant digestive tumors receiving active chemotherapy

Other: Food preference

Patients with digestive cancer traited by immunotherapy

Patients with malignant digestive tumors receiving immunotherapy only

Other: Food preference

Interventions

Evaluate the impact of chemotherapy on the dietary preferences of patients with digestive cancer using a dietary and quality-of-life questionnaire at the beginning, middle and end of the chemotherapy/immunotherapy treatment.

Patients with digestive cancer traited by chemotherapyPatients with digestive cancer traited by immunotherapy

Eligibility Criteria

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

Patients with malignant digestive tumors receiving active chemotherapy

You may qualify if:

  • Able to complete the proposed questionnaires
  • Patients over 18 years of age
  • Non-opposed patients
  • Digestive cancers starting chemotherapy and/or immunotherapy
  • Able to eat by mouth

You may not qualify if:

  • Concomitant treatment for a non-digestive cancer (excluding basal/spinocellular carcinoma and chronic haemopathy)
  • Previous ENT surgery (face/neck)
  • Exclusive enteral feeding (nasogastric tube, gastrostomy) or parenteral nutrition
  • Previous chemotherapy/immunotherapy \< 5 years
  • Individuals deprived of liberty by a judicial or administrative decision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hôpital Edouard Herriot

Lyon, 69003, France

Location

Hôpital Croix Rousse

Lyon, 69004, France

Location

Hôpital Lyon Sud

Pierre-Bénite, 69495, France

Location

MeSH Terms

Conditions

Gastrointestinal NeoplasmsFood Preferences

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesFeeding BehaviorBehavior

Study Design

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

Study Record Dates

First Submitted

October 14, 2024

First Posted

October 15, 2024

Study Start

November 22, 2024

Primary Completion

January 9, 2026

Study Completion

January 9, 2026

Last Updated

March 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations