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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

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