- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06643026
Sensory Evaluation of Taste and Smell in Oncology (SENSEO)
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.
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Lyon, France, 69003
- Hôpital Edouard Herriot
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Lyon, France, 69004
- Hôpital Croix Rousse
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Pierre-Bénite, France, 69495
- Hôpital Lyon Sud
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Patients with digestive cancer traited by chemotherapy
Patients with malignant digestive tumors receiving active chemotherapy
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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.
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Patients with digestive cancer traited by immunotherapy
Patients with malignant digestive tumors receiving immunotherapy only
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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)
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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
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At two month (end of the first cycle of chemotherapy/immunotherapy)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL24_0728
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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