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NCT Number: NCT06643026

Sensory Evaluation of Taste and Smell in Oncology

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Croix Rousse, Lyon, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Food preference

Other

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.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: SENSEO

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 15, 2024
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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