NCT06803381Not yet recruiting
Somesthesia in Cancer Patients: Variability and Influence on Eating Experience
Source: ClinicalTrials.gov · Last updated 6 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Patients with cancer are at high risk of denutrition, in France 39% of these patients suffer of malnutrition. This can affect the immunity, the mental balance and impact the treatment response and the quality of life. Cancer treatments cause many side effects related to food intake as well as sensory alteration, important factor contributing to reduced appetite and inadequate food intake to cancer patients. SOMEST'ALIM2 is a prospective, non-randomized, monocentric, multisite study that aims to evaluate the appreciation of patients with different types of cancer (digestive, gynecological, breast, ear, nose and throat (ENT) or lung) of two different food versions (sweet and salty), in standard and enhanced version. Patients must be under treatment from at least two months, and before food testing their sensory capacity and quantity and the quality of their saliva will be tested. They will also be asked to answer to different questionnaires: socio-demographics, appreciation of food samples, self-assessment of oral symptoms and sensory perceptions, MD, Quality of Life Questionnaire (QLQ-C30) and food quality of life questionnaire. In a context of sensory alterations patients should appreciate more the enhanced food versions. Patients perception of food will be evaluated using a visual analogue scale and results will be correlated with saliva characteristics, subjective sensory perceptions and oral symptoms.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 96 (estimated)
- First submitted
- 27 Jan 2025
- Start date
- 13 Mar 2025
- Primary completion date
- 15 Jun 2025
- Lead sponsor
- Hospices Civils de Lyon
- Diseases
- Lung cancer
- NCT number
- NCT06803381
What you commit to
- Study type: Observational
- Planned participants: 96
- From 13 Mar 2025 to the primary completion date, 15 Jun 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patient having a radiotherapy treatment for an ENT cancer
- Patient with a known food allergy/intolerance to food samples (which may contain dairy products)
- Patient with cognitive disorders and memory loss
Other
- Patient unable to swallow soft food
- Patient having presented nausea and vomiting during the last 24 hours
- Patient with severe inflammation of the mouth or throat (ulcers, mucus)
- Pregnant women or breastfeeding
- Adult under legal protection (guardianship)
Who the study is looking for
- Patient between 18 and 70 years old
- Patient with digestive, breast, gynecologic, ENT or lung cancer
- Patient receiving a cancer treatment from at least two months
- Patient having given his free, informed and express written consent
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Service d'Oncologie Médicale - Hôpital de jour Hôpital de la Croix Rousse Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Service d'Oncologie Médicale - Hôpital de jour Hôpital Edouard Herriot Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.