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Clinical Trials/NCT05816369
NCT05816369
Recruiting
Not Applicable

Taste and Smell Alterations and Oral Nutritional Supplement (ONS) Preferences in Patients With Cancer

University of Bergen1 site in 1 country50 target enrollmentApril 11, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neoplasms
Sponsor
University of Bergen
Enrollment
50
Locations
1
Primary Endpoint
Flavor liking of five different oral nutritional supplement flavors.
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

Patients diagnosed with cancer have a particularly high risk of developing malnutrition due to the disease itself and due to symptoms of cancer treatments that can affect food intake such as reduced appetite, nausea, fatigue, and alterations in taste and smell. Nutritional treatment is essential in the prevention and treatment of malnutrition. Oral nutritional supplements (ONS) are often recommended to cancer patients who need to increase their nutritional intake and are unable to meet their nutritional requirements by consumption of normal food alone. However, patient compliance with ONS depends on sensory acceptability of such products. Therefore, the objective of this study is to investigate preferences of sensory characteristics of ONS among cancer patients. Additionally, possible associations between taste and smell alterations and dietary intake, malnutrition risk, and quality of life will be investigated. The results from this study will optimize recommendations of ONS in the clinical setting and encourage new efforts among manufacturers in developing acceptable sensory characteristics of ONS to cancer patients. Findings from this study will contribute to improving nutritional treatment for cancer patients.

Registry
clinicaltrials.gov
Start Date
April 11, 2023
End Date
September 30, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Ambulatory patients diagnosed with lung cancer
  • Patients receiving cancer treatment of different types
  • Age 18 years or more
  • Provided signed informed consent
  • Understand written and oral Norwegian

Exclusion Criteria

  • Severe mental or cognitive disorders
  • Contraindication to consume ONS (dysphagia, inability to swallow oral nutritional supplements)
  • Allergic or intolerant to any of the ingredients in the ONS
  • Terminally ill patients (\<3 months to live)
  • A clinically significant disease or condition that could, in the investigator's opinion make the patient unfit for the study

Outcomes

Primary Outcomes

Flavor liking of five different oral nutritional supplement flavors.

Time Frame: 30 minutes

To evaluate patient liking of five different oral nutritional supplement flavors using a taste test and a questionnaire with a 9-point Hedonic scale (possible score from 1 to 9) assessing flavor liking. A higher score indicates better liking.

Secondary Outcomes

  • Quality of life.(10 minutes)
  • Liking of ONS characteristics with and without the presence of taste and smell alterations by the 16-item questionnaire Taste and Smell Survey (TSS).(30 minutes)
  • Self-reported taste and smell alterations.(10 minutes)
  • Prevalence of malnutrition risk.(5 minutes)
  • Dietary intake.(3 days)
  • Flavor liking with and without the presence of taste and smell alterations by the 16-item questionnaire Taste and Smell Survey (TSS).(30 minutes)

Study Sites (1)

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