NCT06311877

Effects of Flavor Modification for Management of Radiation Induced Dysgeusia

Effects of Flavor Modification for Management of Radiation Induced Dysgeusia in Head and Neck Cancer Patients

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of South Florida · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dysgeusia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	mBerry	mBerry tablets (.4 grams), which contain protein within the miracle berry called miraculin.
OTHER	No intervention	The control group will not received intervention.

Timeline

• Start date: 2024-09-08
• Primary completion: 2026-12-14
• Completion: 2027-04-14
• First posted: 2024-03-15
• Last updated: 2025-04-18

Locations

1 site across 1 country: United States