The Oncoflavour Study

NCT ID: NCT03525236

Last Updated: 2024-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-19

Study Completion Date

2017-11-01

Brief Summary

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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

Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Taste of 5 flavors

* 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

Group Type EXPERIMENTAL

Tasting of flavours

Intervention Type 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

Interventions

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Tasting 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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nutricia, Inc.

INDUSTRY

Sponsor Role collaborator

University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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An KL Reyners, Prof

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

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University Medical Center Groningen

Groningen, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 33629188 (View on PubMed)

Other Identifiers

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201700363

Identifier Type: -

Identifier Source: org_study_id

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