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

Nutricia

Status: Completed

Conditions: Oncology; Taste, Altered

Treatments: Dietary Supplement: Fortimel/Nutridrink Compact Protein

Study type: Interventional

Funder types: Industry

Identifiers

NCT05518825

SBB21R&36579

Details and patient eligibility

About

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

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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64 participants in 1 patient group

Fortimel/Nutridrink Compact Protein

Experimental group

Description:

Twice daily serving of the study product

Treatment:

Dietary Supplement: Fortimel/Nutridrink Compact Protein