Oral Nutritional Supplement Preferences in Patients With Cancer

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05816369
• Other study ID #: Cancer Taste Study
• Status: Recruiting
• Phase: N/A
• Start date: April 11, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: November 2023
• Source: University of Bergen
• Contact: Simon N Dankel, Professor
• Phone: +47 943 08 637
• Email: simon.dankel[@]uib.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition
• Neoplasms

Intervention

Other:
• Taste session of five ONS flavors
Patients will taste a small sample (30 mL) of five ONS flavors and report their taste experiences by completing questionnaires of each flavor during the taste session. Participants will also complete a malnutrition risk screening (MST), a three-day food diary, questionnaires of self-reported taste and smell changes (TSS), and quality of life (RAND-36).

Locations

Country	Name	City	State
Norway	University of Bergen	Bergen	Vestland

Sponsors (3)

Lead Sponsor	Collaborator
University of Bergen	Haukeland University Hospital, Smartfish AS

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flavor liking of five different oral nutritional supplement flavors.	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.	30 minutes
Secondary	Self-reported taste and smell alterations.	Using the 16-item questionnaire Taste and Smell Survey (TSS). TSS consists of nine questions regarding changes in the sense of taste (possible score 0-10), five questions regarding changes in the sense of smell (possible score 0-6), and two global questions regarding quality of life. A higher total score indicates a higher number of aspects of taste and smell alterations.	10 minutes
Secondary	Prevalence of malnutrition risk.	Malnutrition risk will be defined using the two-item questionnaire Malnutrition Screening Tool (MST). MST consists of one question regarding changes in weight (possible score 0-4) and one questions regarding changes in food intake (possible score 0-1). A total score of 2 or more defines a patient to be at risk of malnutrition.	5 minutes
Secondary	Dietary intake.	Dietary intake will be defined using a three-day patient food diary. The three-day patient food diary consists of two reports from week days and one report from a weekend day. Patients will report everything that is consumed during these selected days.The average intake of macro- and micronutrients will be calculated.	3 days
Secondary	Quality of life.	Using the 36-item questionnaire RAND-36. RAND-36 consists of eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions (possible score 0-100). A lower score indicates poorer quality of life.	10 minutes
Secondary	Flavor liking with and without the presence of taste and smell alterations by the 16-item questionnaire Taste and Smell Survey (TSS).	Using a 9-point Hedonic scale (possible score from 1 to 9) assessing flavor liking. A higher score indicates better liking. The presence of self reported taste and smell alterations will be defined by the answer response "yes" to any of the six questions in the Taste and Smell Survey (TSS) addressing the presence of taste and smell alterations.	30 minutes
Secondary	Liking of ONS characteristics with and without the presence of taste and smell alterations by the 16-item questionnaire Taste and Smell Survey (TSS).	Using a taste test and questionnaires with a 5-point Just About Right (JAR) scale regarding flavor intensity, acidity, sweetness, and viscosity. The presence of self reported taste and smell alterations will be defined by the answer response "yes" to any of the six questions in the Taste and Smell Survey (TSS) addressing the presence of taste and smell alterations.	30 minutes