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The Oncoflavour Study

Product Validation by Cancer Patients - Oncoflavour

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03525236
Enrollment
50
Registered
2018-05-15
Start date
2017-06-19
Completion date
2017-11-01
Last updated
2024-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

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

Interventions

OTHERTasting of flavours

* 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

Sponsors

Nutricia, Inc.
CollaboratorINDUSTRY
University Medical Center Groningen
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Liking of 5 different oral nutritional supplements with adapted flavors20 minutesTo evaluate patient liking and perception about 5 new flavors on a 10-point scale via a sip test

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026