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Trial Title:
Effects of Flavor Modification for Management of Radiation Induced Dysgeusia
NCT ID:
NCT06311877
Condition:
Dysgeusia
Conditions: Official terms:
Dysgeusia
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
mBerry
Description:
mBerry tablets (.4 grams), which contain protein within the miracle berry called
miraculin.
Arm group label:
Experimental group given mBerry tablet
Intervention type:
Other
Intervention name:
No intervention
Description:
The control group will not received intervention.
Arm group label:
Control group not receiving mBerry
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.
Detailed 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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
No
Start date:
May 1, 2024
Completion date:
February 14, 2025
Lead sponsor:
Agency:
University of South Florida
Agency class:
Other
Source:
University of South Florida
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06311877