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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

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