Status:
COMPLETED
SOMESThesia and ALIMentation
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Head and Neck Cancers
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Cancer patients are at high risk for undernutrition. A study with head and neck cancer patients showed that 50% suffered from undernutrition (Prevost et al., 2014). Sensory alterations may also involv...
Eligibility Criteria
Inclusion
- All subjects:
- Person between 18 and 65 years
- Person having given free, informed, express written consent
- Person affiliated to a French social security system
- Person with a body mass superior to 18 kg/m².
- Person able to come once to the Institut Paul Bocuse
- Patients with head and neck cancer with chemotherapy:
- \- Patient diagnosed with squamous cell head and neck cancer with the following treatment regimen: Surgery + radiochemotherapy or radiochemotherapy alone
- Patients with head and neck cancer without chemotherapy:
- \- Patient diagnosed with squamous cell head and neck cancer with the following treatment regimen: Surgery + radiation therapy or radiation therapy alone
- Healthy volunteers :
- Volunteer who is +/- 5 years of age relative to the patient to whom they are matched.
- Volunteer of the same sex as the patient to whom they are matched
- Volunteer with the same smoking status as the patient to whom they are matched
- Volunteer who has not had cancer within 5 years at the time of inclusion
- Volunteer with no current treatment that may affect taste and smell perception
Exclusion
- All subjects:
- Person with a known food allergy/intolerance (lactose or milk protein) or unable to consume dairy or solid products (e.g., chocolate milk pudding, chocolate jelly)
- Person with a known allergy to chili (or capsaicin)
- Person with diagnosed total ageusia
- Person with diagnosed total anosmia
- Person who has used artificial feeding within 2 months prior to inclusion.
- Person who has lost more than 10% of baseline weight in the 2 months prior to inclusion
- Person deprived of liberty or under guardianship or trusteeship.
- Pregnant or breastfeeding woman
- Person deprived of liberty by a judicial or administrative decision
- Person under guardianship or protection of vulnerable adults
- Person with trismus (reduced jaw opening or limited jaw range of motion)
- A person who is unable to extend his or her tongue
- Person who has had surgery on the mobile tongue and/or base of the tongue
- Person unable to swallow soft foods
- Person who has had or is suspected of having had Corona Virus Disease (COVID)-19 within the last 6 months.
- Patients with head and neck cancer:
- Patient receiving immunotherapy
- Patient treated with surgery only.
Key Trial Info
Start Date :
May 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 14 2023
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT05272917
Start Date
May 20 2022
End Date
April 14 2023
Last Update
September 9 2025
Active Locations (2)
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1
Centre de recherche de l'Institut Paul Bocuse
Écully, France, 69131
2
Service d'Oncologie médicale, Hôpital de la Croix-Rousse
Lyon, France, 69004