The Oncoflavour Study

NCT03525236 | Completed

• 1 other identifier: 201700363
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Taste of 5 flavors

EXPERIMENTAL

* 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

Interventions

Tasting of flavours OTHER

* 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

Taste of 5 flavors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 18 years old
• Ability to complete and comprehend questionnaires provided
• Undergoing systemic cancer treatment (chemotherapy or concurrent chemoradiotherapy, radiotherapy, targeted therapy or immunotherapy)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Nutricia, Inc.: collaborator

Study Sites (1)

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

Related Publications (1)

• de Haan JJ, Renken RJ, Moshage Y, Kluifhooft DA, Corbier C, Daly LE, Blanchard H, Reyners AKL. Self-reported taste and smell alterations and the liking of oral nutritional supplements with sensory-adapted flavors in cancer patients receiving systemic antitumor treatment. Support Care Cancer. 2021 Oct;29(10):5691-5699. doi: 10.1007/s00520-021-06049-4. Epub 2021 Feb 25.

  PMID: 33629188 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• An KL Reyners, Prof

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: May 15, 2018
• Study Start: June 19, 2017
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: April 19, 2024

Record last verified: 2024-04

Locations

NL (1)