Effects of Flavor Modification for Management of Radiation Induced Dysgeusia

NCT06311877 | Enrolling By Invitation

• 1 other identifier: 6795
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dysgeusia

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• M.D. Anderson Dysphagia Inventory (MDADI)

  Bi-weekly for 8 weeks

• Functional Oral Intake Scale (FOIS)

  Bi-weekly for 8 weeks

Other Outcomes (1)

• Patients weight measurement

  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.

Study Arms (2)

Experimental group given mBerry tablet

EXPERIMENTAL

For the experiment group, the clinician will be providing participant with daily 0.4 gram mBerry tablets (total of 112 tablets) to consume twice a day (for two meals) over an 8-week period. The participant will be provided with a log form to track mBerry use for the two meals each day for the 8-week period. They will be requested to bring log to each of the clinical visits which include bi-weekly taste assessments.

Dietary Supplement: mBerry

Control group not receiving mBerry

ACTIVE COMPARATOR

The control group will not be given a placebo. The control group will come to clinic for bi-weekly taste assessments.

Other: No intervention

Interventions

mBerry DIETARY_SUPPLEMENT

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

Experimental group given mBerry tablet

No intervention OTHER

The control group will not received intervention.

Control group not receiving mBerry

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 18 years
• Diagnosis of mandibular cancer, tonsillar cancer, and lingual cancer
• Receiving primary or adjuvant radiation therapy

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

University of South Florida

Tampa, Florida, 33606, United States

Location

MeSH Terms

Conditions

Dysgeusia

Condition Hierarchy (Ancestors)

Taste Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jennifer Larsson

  University of South Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Speech-Language Pathologist

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 15, 2024
• Study Start: September 8, 2024
• Primary Completion (Estimated): December 14, 2026
• Study Completion (Estimated): April 14, 2027
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)