Effects of Flavor Modification for Management of Radiation Induced Dysgeusia
NCT ID: NCT06311877
Last Updated: 2025-04-18
Study Results
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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ENROLLING_BY_INVITATION
NA
30 participants
INTERVENTIONAL
2024-09-08
2027-04-14
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental group given mBerry tablet
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.
mBerry
mBerry tablets (.4 grams), which contain protein within the miracle berry called miraculin.
Control group not receiving mBerry
The control group will not be given a placebo. The control group will come to clinic for bi-weekly taste assessments.
No intervention
The control group will not received intervention.
Interventions
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mBerry
mBerry tablets (.4 grams), which contain protein within the miracle berry called miraculin.
No intervention
The control group will not received intervention.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of mandibular cancer, tonsillar cancer, and lingual cancer
* Receiving primary or adjuvant radiation therapy
Exclusion Criteria
* 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.
18 Years
90 Years
ALL
No
Sponsors
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University of South Florida
OTHER
Responsible Party
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Jennifer Larsson
Speech-Language Pathologist
Principal Investigators
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Jennifer Larsson
Role: PRINCIPAL_INVESTIGATOR
University of South Florida
Locations
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University of South Florida
Tampa, Florida, United States
Countries
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Other Identifiers
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6795
Identifier Type: -
Identifier Source: org_study_id
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