Effects of Flavor Modification for Management of Radiation Induced Dysgeusia

University of South Florida

Status: Invitation-only

Conditions: Dysgeusia

Treatments: Other: No intervention; Dietary Supplement: mBerry

Study type: Interventional

Funder types: Other

Identifiers

NCT06311877

6795

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Experimental group given mBerry tablet

Experimental group

Description:

For the experiment group, the clinician will be providing participant with daily 0.4 gram mBerry tablets (total of 112 tablets) to consume twice a day (for two meals) over an 8-week period. The participant will be provided with a log form to track mBerry use for the two meals each day for the 8-week period. They will be requested to bring log to each of the clinical visits which include bi-weekly taste assessments.

Treatment:

Dietary Supplement: mBerry

Control group not receiving mBerry

Active Comparator group

Description:

The control group will not be given a placebo. The control group will come to clinic for bi-weekly taste assessments.

Treatment:

Other: No intervention