Viewing Study NCT06311877



Ignite Creation Date: 2024-05-06 @ 8:15 PM
Last Modification Date: 2024-10-26 @ 3:23 PM
Study NCT ID: NCT06311877
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-03-15
First Post: 2024-03-06

Brief Title: Effects of Flavor Modification for Management of Radiation Induced Dysgeusia
Sponsor: University of South Florida
Organization: University of South Florida

Study Overview

Official Title: Effects of Flavor Modification for Management of Radiation Induced Dysgeusia in Head and Neck Cancer Patients
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 mBerrys potential in alleviating dysgeusia aiding patients in achieving better nutritional status and quality of lifeThis 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None