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The Oncoflavour Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03525236
Recruitment Status : Completed
First Posted : May 15, 2018
Last Update Posted : May 15, 2018
Sponsor:
Collaborator:
Nutricia, Inc.
Information provided by (Responsible Party):
A.K.L. Reyners, University Medical Center Groningen

Study Description
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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

Condition or disease Intervention/treatment Phase
Cancer Other: Tasting of flavours Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Product Validation by Cancer Patients - Oncoflavour
Actual Study Start Date : June 19, 2017
Actual Primary Completion Date : November 1, 2017
Actual Study Completion Date : November 1, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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
 Other: 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


Outcome Measures
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Primary Outcome Measures :
  1. Liking of 5 different oral nutritional supplements with adapted flavors [ Time Frame: 20 minutes ]
    To evaluate patient liking and perception about 5 new flavors on a 10-point scale via a sip test


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03525236


Locations
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Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9713 GZ
Sponsors and Collaborators
University Medical Center Groningen
Nutricia, Inc.
Investigators
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Principal Investigator: An KL Reyners, Prof University Medical Center Groningen
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: A.K.L. Reyners, Principal investigator, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT03525236    
Other Study ID Numbers: 201700363
First Posted: May 15, 2018    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No