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Clinical Trials/NCT06643026
NCT06643026
Completed
Not Applicable

Sensory Evaluation of Taste and Smell in Oncology

Hospices Civils de Lyon3 sites in 1 country69 target enrollmentNovember 22, 2024
InterventionsFood preference

Overview

Phase
Not Applicable
Intervention
Food preference
Conditions
Digestive Cancers
Sponsor
Hospices Civils de Lyon
Enrollment
69
Locations
3
Primary Endpoint
Proportion of patient with changes in food preferences of digestive cancer patients at the end of the first cycle of chemotherapy.
Status
Completed
Last Updated
last month

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 22, 2024
End Date
January 9, 2026
Last Updated
last month
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Arms & Interventions

Patients with digestive cancer traited by chemotherapy

Patients with malignant digestive tumors receiving active chemotherapy

Intervention: Food preference

Patients with digestive cancer traited by immunotherapy

Patients with malignant digestive tumors receiving immunotherapy only

Intervention: Food preference

Outcomes

Primary Outcomes

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

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

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

Study Sites (3)

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