Clinical trial NCT06311877: Effects of Flavor Modification for Management of Radiation Induced Dysgeusia
Official title: Effects of Flavor Modification for Management of Radiation Induced Dysgeusia in Head and Neck Cancer Patients
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Dysgeusia
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: 5-Point Hedonic Rating Scale
timeFrame: Bi-weekly for 8 weeks
measure: Chemotherapy-induced Taste Alteration Scale (CITAS)
timeFrame: Bi-weekly for 8 weeks
Secondary outcomes:
measure: M.D. Anderson Dysphagia Inventory (MDADI)
timeFrame: Bi-weekly for 8 weeks
measure: Functional Oral Intake Scale (FOIS)
timeFrame: Bi-weekly for 8 weeks
Other outcomes:
measure: Patients weight measurement
timeFrame: 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.
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
Study officials:
affiliation: University of South Florida
name: Jennifer Larsson
role: PRINCIPAL_INVESTIGATOR
References: