Clinical trial NCT05816369: Oral Nutritional Supplement Preferences in Patients With Cancer
Official title: Taste and Smell Alterations and Oral Nutritional Supplement (ONS) Preferences in Patients With Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neoplasms
Malnutrition
Lead sponsor: University of Bergen
Sponsor class: OTHER
Collaborators: name: Haukeland University Hospital
name: Smartfish AS
First posted: 2023-04-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Flavor liking of five different oral nutritional supplement flavors.
timeFrame: 30 minutes
Secondary outcomes:
measure: Self-reported taste and smell alterations.
timeFrame: 10 minutes
measure: Prevalence of malnutrition risk.
timeFrame: 5 minutes
measure: Dietary intake.
timeFrame: 3 days
measure: Quality of life.
timeFrame: 10 minutes
measure: Flavor liking with and without the presence of taste and smell alterations by the 16-item questionnaire Taste and Smell Survey (TSS).
timeFrame: 30 minutes
measure: Liking of ONS characteristics with and without the presence of taste and smell alterations by the 16-item questionnaire Taste and Smell Survey (TSS).
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: University of Bergen
state: Vestland
Study officials:
affiliation: University of Bergen
name: Simon N Dankel, Professor
role: PRINCIPAL_INVESTIGATOR
References: