Effects of Flavor Modification for Management of Radiation Induced Dysgeusia

Dysgeusia Clinical Trial

Official title:

Effects of Flavor Modification for Management of Radiation Induced Dysgeusia in Head and Neck Cancer Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06311877
• Other study ID #: 6795
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: February 14, 2025

Study information

• Verified date: March 2024
• Source: University of South Florida
• Contact: Jennifer T Larsson
• Phone: 9545522142
• Email: jentlarsson[@]usf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Intervention for dysgeusia in head and neck cancer patients undergoing radiation therapy. This research proposal aims to investigate potential benefits of mBerry in improving quality of life and nutritional outcome in head and neck cancer patients' post-radiation therapy. Our hypothesis is that cancer patients undergoing radiation therapy will benefit from use of miracle berry in treatment of dysgeusia.

Description:

Dysgeusia, characterized by altered taste, is a common side effect of radiation used in oropharyngeal cancer treatment. Radiation affects taste buds, leading to issues like loss of appetite, malnutrition, dependence on feeding tubes, dysphagia, and impacts social and overall quality of life. Patients often report bitter, metallic or no taste with food after radiation. Miracle berries, known for interacting with sweet taste receptors, could potentially transform acidic tastes into sweet ones.

The aim is to explore mBerry's potential in alleviating dysgeusia, aiding patients in achieving better nutritional status and quality of life.This study includes the use of mBerry tablets, which contain protein within the miracle berry called miraculin, for the treatment of radiation-induced dysgeusia. mBerry is not approved by the Food and Drug Administration (FDA) for the treatment of radiation-induced dysgeusia. It is being used as part of this research study to find out if mBerry tablets improve taste outcomes among head and neck cancer patients after radiation therapy.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: February 14, 2025
• Est. primary completion date: February 14, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Over 18 years

• Diagnosis of mandibular cancer, tonsillar cancer, and lingual cancer

• Receiving primary or adjuvant radiation therapy

Exclusion Criteria:

• Received a total glossectomy or total laryngectomy.

• Patients with allergies to peanut, latex, peach, or soy will be excluded as they are at increased risk of allergy to mBerry.

• Diagnosis of diabetes as well as prediabetic patients and those that are taking Metformin.

Related Conditions & MeSH terms

• Dysgeusia

Intervention

Dietary Supplement:
• mBerry
mBerry tablets (.4 grams), which contain protein within the miracle berry called miraculin.

Other:
• No intervention
The control group will not received intervention.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patients weight measurement	Weight	Patients will be seen for 4 follow-up appointments in the 8 week time frame of the study. The patient will be weighed at the 1st and 4th follow-up visit.
Primary	5-Point Hedonic Rating Scale	Taste Test Scale used to assessing liking or preference of taste of a product. Dislike Very Much: Assigned a value of 1, this represents strong disliking. Dislike Slightly: Assigned a value of 2, indicating mild disliking. Neither Like nor Dislike: Assigned a value of 3, representing a neutral response.; Like Slightly: Assigned a value of 4, indicating mild liking. Like Very Much: Assigned a value of 5, representing strong liking. The higher the number scored indicates the participants enjoyed the taste vs the lower the number participant liked the taste less.	Bi-weekly for 8 weeks
Primary	Chemotherapy-induced Taste Alteration Scale (CITAS)	Perceived taste scale- Self- administered questionnaire of 18 items evaluated on a five-point. Using a Likert scale 1-5 (where 1 = no difficulty or absence of the disturbance and 5 = maximum difficulty or disturbance). Higher scores indicate more severe taste alterations.	Bi-weekly for 8 weeks
Secondary	M.D. Anderson Dysphagia Inventory (MDADI)	Patient questionaire on swallow function. Scored on a scale score from 0 to 100. Lower the scores indicate a greater impact of dysphagia on the patients quality of life.	Bi-weekly for 8 weeks
Secondary	Functional Oral Intake Scale (FOIS)	Level of least restrictive diet- the higher the number the participant is able to eat by mouth the lesser of number the patient might be reliable on a feeding tube	Bi-weekly for 8 weeks