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Oral Nutritional Supplement Preferences in Patients With Cancer

NCT ID: NCT05816369

Last Updated: 2023-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-11

Study Completion Date

2024-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Neoplasms Malnutrition

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Taste preferences of five ONS flavors

Taste session with corresponding questionnaires

Group Type EXPERIMENTAL

Taste session of five ONS flavors

Intervention Type 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).

Interventions

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Taste session of five ONS flavors

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).

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Haukeland University Hospital

OTHER

Sponsor Role collaborator

Smartfish AS

INDUSTRY

Sponsor Role collaborator

University of Bergen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Simon N Dankel, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Bergen

Locations

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University of Bergen

Bergen, Vestland, Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Simon N Dankel, Professor

Role: CONTACT

Phone: +47 943 08 637

Email: [email protected]

Facility Contacts

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Simon N Dankel, PhD

Role: primary

Other Identifiers

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Cancer Taste Study

Identifier Type: -

Identifier Source: org_study_id