Oral Nutritional Supplement Preferences in Patients With Cancer

NCT05816369 | Unknown

• 1 other identifier: Cancer Taste Study
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasms; Malnutrition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Self-reported taste and smell alterations.

  10 minutes

• Prevalence of malnutrition risk.

  5 minutes

• Dietary intake.

  3 days

• Quality of life.

  10 minutes

• Flavor liking with and without the presence of taste and smell alterations by the 16-item questionnaire Taste and Smell Survey (TSS).

  30 minutes

Study Arms (1)

Taste preferences of five ONS flavors

EXPERIMENTAL

Taste session with corresponding questionnaires

Other: Taste session of five ONS flavors

Interventions

Taste session of five ONS flavors OTHER

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).

Taste preferences of five ONS flavors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bergen: lead
• Haukeland University Hospital: collaborator
• Smartfish AS: collaborator

Study Sites (1)

University of Bergen

Bergen, Vestland, 5021, Norway

RECRUITING

MeSH Terms

Conditions

Neoplasms; Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Simon N Dankel, Professor

  University of Bergen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon N Dankel, Professor

CONTACT

+47 943 08 637; simon.dankel@uib.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: April 18, 2023
• Study Start: April 11, 2023
• Primary Completion: December 30, 2023
• Study Completion: September 30, 2024
• Last Updated: December 4, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)