NeoplasmsNCT05816369
Oral Nutritional Supplement Preferences in Patients With Cancer
A study testing Taste session of five ONS flavors in people with Neoplasms and Malnutrition, run by University of Bergen at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Malnutrition
- What is being tested?
- Taste session of five ONS flavors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteNorway
- Study dates
- 11 Apr 2023to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
University of Bergen
Bergen, Vestland, 5021
Simon N Dankel, PhD, +4794308637
About this study
Official title: Taste and Smell Alterations and Oral Nutritional Supplement (ONS) Preferences in Patients With Cancer
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.
- Conditions
- Neoplasms, Malnutrition
- Being tested
- Taste session of five ONS flavors
- Medical subject headings
- Neoplasms, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taste session of five ONS flavorsOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Taste preferences of five ONS flavors | Experimental | Taste session with corresponding questionnaires Receives: Other: Taste session of five ONS flavors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes
Secondary outcomes (6)
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.
Measured: 10 minutes
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.
Measured: 5 minutes
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.
Measured: 3 days
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.
Measured: 10 minutes
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.
Measured: 30 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).
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.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start11 Apr 2023
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- Haukeland University Hospital, Smartfish AS
- Responsible party
- Sponsor
- Investigators
- Simon N Dankel, Professor, Principal investigator, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05816369
- Sponsor's protocol ID
- Cancer Taste Study
- Status last verified
- Nov 2023
- First submitted
- 15 Mar 2023
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taste and Smell Alterations and Oral Nutritional Supplement (ONS) Preferences in Patients With Cancer
- ClinicalTrials.gov ID
- NCT05816369
- Acronym / sponsor ID
- Cancer Taste Study
- Conditions
- Neoplasms, Malnutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- Haukeland University Hospital, Smartfish AS
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Taste preferences of five ONS flavors | Experimental | Other: Taste session of five ONS flavorsTaste session with corresponding questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Taste session of five ONS flavorsPatients 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). | Other | Taste preferences of five ONS flavors |
Primary outcome
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.
6 secondary outcomes
Self-reported taste and smell alterations.
Time frame: 10 minutes
Prevalence of malnutrition risk.
Time frame: 5 minutes
Dietary intake.
Time frame: 3 days
Quality of life.
Time frame: 10 minutes
Flavor liking with and without the presence of taste and smell alterations by the 16-item questionnaire Taste and Smell Survey (TSS).
Time frame: 30 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).
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon N Dankel, Professor principal investigator
University of Bergen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Taste session of five ONS flavors in people with Neoplasms and Malnutrition, run by University of Bergen at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simon N Dankel, Professor (+47 943 08 637, simon.dankel@uib.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flavor liking of five different oral nutritional supplement flavors. (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2023.