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Oral Nutritional Supplement Preferences in Patients With Cancer

Primary Purpose

Neoplasms, Malnutrition

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Taste session of five ONS flavors
Sponsored by
University of Bergen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Taste preferences of five ONS flavors

    Arm Description

    Taste session with corresponding questionnaires

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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.

    Full Information

    First Posted
    March 15, 2023
    Last Updated
    March 31, 2023
    Sponsor
    University of Bergen
    Collaborators
    Haukeland University Hospital, Smartfish AS
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05816369
    Brief Title
    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

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 11, 2023 (Anticipated)
    Primary Completion Date
    September 30, 2023 (Anticipated)
    Study Completion Date
    September 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Bergen
    Collaborators
    Haukeland University Hospital, Smartfish AS

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neoplasms, Malnutrition

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Taste preferences of five ONS flavors
    Arm Type
    Experimental
    Arm Description
    Taste session with corresponding questionnaires
    Intervention Type
    Other
    Intervention Name(s)
    Taste session of five ONS flavors
    Intervention Description
    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).
    Primary Outcome Measure Information:
    Title
    Flavor liking of five different oral nutritional supplement flavors.
    Description
    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.
    Time Frame
    30 minutes
    Secondary Outcome Measure Information:
    Title
    Self-reported taste and smell alterations.
    Description
    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.
    Time Frame
    10 minutes
    Title
    Prevalence of malnutrition risk.
    Description
    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.
    Time Frame
    5 minutes
    Title
    Dietary intake.
    Description
    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.
    Time Frame
    3 days
    Title
    Quality of life.
    Description
    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.
    Time Frame
    10 minutes
    Title
    Flavor liking with and without the presence of taste and smell alterations by the 16-item questionnaire Taste and Smell Survey (TSS).
    Description
    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.
    Time Frame
    30 minutes
    Title
    Liking of ONS characteristics with and without the presence of taste and smell alterations by the 16-item questionnaire Taste and Smell Survey (TSS).
    Description
    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.
    Time Frame
    30 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Simon N Dankel, Professor
    Phone
    +47 943 08 637
    Email
    simon.dankel@uib.no
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Simon N Dankel, Professor
    Organizational Affiliation
    University of Bergen
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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