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Trial Title:
Oral Nutritional Supplement Preferences in Patients With Cancer
NCT ID:
NCT05816369
Condition:
Neoplasms
Malnutrition
Conditions: Official terms:
Malnutrition
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Taste session of five ONS flavors
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).
Arm group label:
Taste preferences of five ONS flavors
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Bergen
Address:
City:
Bergen
Zip:
5021
Country:
Norway
Status:
Recruiting
Contact:
Last name:
Simon N Dankel, PhD
Phone:
+4794308637
Start date:
April 11, 2023
Completion date:
September 30, 2024
Lead sponsor:
Agency:
University of Bergen
Agency class:
Other
Collaborator:
Agency:
Haukeland University Hospital
Agency class:
Other
Collaborator:
Agency:
Smartfish AS
Agency class:
Industry
Source:
University of Bergen
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05816369