The Oncoflavour Study

Study Overview
=================
Brief Summary
-----------------
Oral nutritional supplements (ONS) are often prescribed for malnourished patients to help improve nutritional status. Commonly in cancer patients taste and smell alterations and side effects of treatment can affect the palatability and compliance to ONS. A variety of flavours and styles are available of ONS however research of the palatability of these in cancer patients is limited. This study aims to evaluate specific flavours created based on the taste changes occuring during treatment. We aim to evaluate the patient liking and evaluation of 5 flavors in 3 different types of flavour-sensations: Warming/spicy sensation: to trigger the senses and bring new sensations Cooling/fresh sensation: to have a fresh mouthfeel and lighter base perception Neutral: to avoid that patients experience additional flavour and let them the opportunity to mix it with other food

Official Title
-----------------
Product Validation by Cancer Patients - Oncoflavour

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Other: Tasting of flavours


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 years old Ability to complete and comprehend questionnaires provided Undergoing systemic cancer treatment (chemotherapy or concurrent chemoradiotherapy, radiotherapy, targeted therapy or immunotherapy) Exclusion Criteria: Uncertainty about the willingness or ability of the patient to comply with the protocol requirements (no impairment and no cognitive impairments) Coexisting-morbidities affecting taste or smell function Lactose Intolerance or Galactosaemia Dysphagia Diabetics Food allergies/intolerances to ingredients present in the product No rejection of lemon, red fruits, exotic fruit, yellow fruit flavours.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Taste of 5 flavors<br>Each patient will taste 5 products, in sequential-monadic test, randomized, one by one. Patients will take few sips of each study product, ideally in isolation (avoid influence of other patients) For each product tasted the subjects will be asked to answer a questionnaire including 1 question on the palatability of the product using a 10-point hedonic scale and a more detailed organoleptic evaluation of the product. Between product tastings, participants will have a 10 minutes break to rinse their mouth and fill in a questionnaire assessing sensory changes | Other: Tasting of flavours<br>* Each patient will taste 5 products, in sequential-monadic test, randomized, one by one. Patients will take few sips of each study product, ideally in isolation (avoid influence of other patients) For each product tasted the subjects will be asked to answer a questionnaire including 1 question on the palatability of the product using a 10-point hedonic scale and a more detailed organoleptic evaluation of the product. Between product tastings, participants will have a 10 minutes break to rinse their mouth and fill in a questionnaire assessing sensory changes<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liking of 5 different oral nutritional supplements with adapted flavors | To evaluate patient liking and perception about 5 new flavors on a 10-point scale via a sip test | 20 minutes |