Clinical trial · Observational
Somesthesia in Cancer Patients: Variability and Influence on Eating Experience
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Digestive Cancers | — | UNRESOLVED | — |
| Ear Cancer | Malignant Ear Neoplasm | ALIAS | 0.90 |
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Nose Cancer | — | UNRESOLVED | — |
| Throat Cancer | Throat Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Food tasting | Other | — | UNRESOLVED |
| Questionnaires | Other | — | UNRESOLVED |
| Salivary test | Other | — | UNRESOLVED |
| sensory capacity evaluation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with cancer and under treatment from at least two months.
- description
- The study will involve adult subjects with different types of cancer (digestive, gynecological, breast, ENT, lung) receiving active anticancer treatment (chemotherapy, targeted therapy, immunotherapy, etc., except patients undergoing ENT radiotherapy) in a standard of care program. Patients participating to the trial will perform a salivary test, an evaluation of the sensory capacity, food tasting and will answer to different questionnaires
- interventionNames
- Other: Salivary test
- Other: Food tasting
- Other: Questionnaires
- Other: sensory capacity evaluation
Primary outcomes (1)
- measure
- visual analogue scale (VAS) score
- timeFrame
- Day 1
- description
- The score difference of a visual analogue scale (VAS) (0 : I don't like at all to 100 : I like a lot) will be used to evaluate perception of patients with cancer on two different versions of food. The scale unit will be in mm and the difference in VAS score between the two food categories will be compared (hedonic delta).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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 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) * Patient with cognitive disorders and memory loss * Pregnant women or breastfeeding * Adult under legal protection (guardianship)
References
Publications (0)
Data not yet available