Digestive CancersSENSEONCT06643026
Sensory Evaluation of Taste and Smell in Oncology
An observational study of Digestive Cancers, run by Hospices Civils de Lyon at 3 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Digestive Cancers
- What is being tested?
- Food preference
- How many people
- 69 participants
- Where
- 3 sitesFrance
- Study dates
- 22 Nov 2024to 9 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with malignant digestive tumors receiving active chemotherapy
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hôpital Edouard Herriot
Lyon, 69003
Hôpital Croix Rousse
Lyon, 69004
Hôpital Lyon Sud
Pierre-Bénite, 69495
About this study
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).
Read more
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.
- Conditions
- Digestive Cancers
- Being tested
- Food preference
- Keywords
- digestive cancers, chemotherapy, food preference, sensory perceptions
- Medical subject headings
- Gastrointestinal Neoplasms, Food Preferences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food preferenceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with digestive cancer traited by chemotherapy | Patients with malignant digestive tumors receiving active chemotherapy Receives: Other: Food preference | |
| Patients with digestive cancer traited by immunotherapy | Patients with malignant digestive tumors receiving immunotherapy only Receives: Other: Food preference |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At two month (end of the first cycle of chemotherapy/immunotherapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start22 Nov 2024
- Primary completion9 Jan 2026
- Study completion9 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive CancersStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06643026
- Sponsor's protocol ID
- 69HCL24_0728
- Acronym
- SENSEO
- Status last verified
- Mar 2026
- First submitted
- 14 Oct 2024
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory Evaluation of Taste and Smell in Oncology
- ClinicalTrials.gov ID
- NCT06643026
- Acronym / sponsor ID
- SENSEO / 69HCL24_0728
- Conditions
- Digestive Cancers
- Keywords
- digestive cancers, chemotherapy, food preference, sensory perceptions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 22 Nov 2024 (actual)
- Primary completion
- 9 Jan 2026 (actual)
- Study completion
- 9 Jan 2026 (actual)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with digestive cancer traited by chemotherapy | – | Other: Food preferencePatients with malignant digestive tumors receiving active chemotherapy |
| Patients with digestive cancer traited by immunotherapy | – | Other: Food preferencePatients with malignant digestive tumors receiving immunotherapy only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with malignant digestive tumors receiving active chemotherapy
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food preferenceEvaluate 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. | Other | Patients with digestive cancer traited by chemotherapy, Patients with digestive cancer traited by immunotherapy |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Digestive Cancers, run by Hospices Civils de Lyon at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.