Assessment of ONS-flavour Preference in Cancer Patients With and Without Taste Alterations

NCT ID: NCT05518825

Last Updated: 2023-08-24

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

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-06

Study Completion Date

2023-03-28

Brief Summary

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A single arm intervention study examining ONS-flavour preference in cancer patients with and without taste alterations

Detailed Description

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Conditions

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Oncology Taste, Altered

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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Fortimel/Nutridrink Compact Protein

Twice daily serving of the study product

Group Type EXPERIMENTAL

Fortimel/Nutridrink Compact Protein

Intervention Type DIETARY_SUPPLEMENT

Twice daily serving of the study product

Interventions

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Fortimel/Nutridrink Compact Protein

Twice daily serving of the study product

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

1. Being diagnosed with cancer
2. Undergoing, or having undergone systemic anti-cancer treatment or radiotherapy in the past 12 months.
3. Age \> 18 years
4. Written informed consent

Exclusion Criteria

1. Taste and smell alterations not caused by the cancer or anti-cancer treatment
2. Galactosaemia
3. Use of thickener to be able to swallow safely
4. Allergies to any of the product ingredients or any of the flavours
5. Current prescription for ONS, enteral nutrition or parenteral nutrition
6. Diabetes mellitus Type I or Type II
7. Open sores or severe inflammation in the mouth or throat
8. Undergoing dialysis
9. Hepatic encephalopathy
10. Patients with heart failure who have symptoms of heart failure at rest and/or are unable to carry on any physical activity without discomfort
11. Known pregnancy or lactation
12. Average alcohol use of \> 21 glasses per week for men or \> 14 glasses per week for women or drug abuse in opinion of the investigator
13. Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
14. Participation in any other studies involving food products concomitantly or within two weeks prior to entry into the study.
15. Employees of Nutricia Research and/or partners, parents, children and brothers/sisters of employees
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nutricia Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nutricia Clinical Research Unit

Utrecht, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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SBB21R&36579

Identifier Type: -

Identifier Source: org_study_id

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