Effects of Flavor Modification for Management of Radiation Induced Dysgeusia

Not Applicable

Not yet recruiting

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.

Recruitment & Eligibility

Inclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
Experimental group given mBerry tablet	mBerry	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.
Control group not receiving mBerry	No intervention	The control group will not be given a placebo. The control group will come to clinic for bi-weekly taste assessments.

Primary Outcome Measures

Name	Time	Method
Chemotherapy-induced Taste Alteration Scale (CITAS)	Bi-weekly for 8 weeks	Perceived taste scale- Self- administered questionnaire of 18 items evaluated on a five-point. Using a Likert scale 1-5 (where 1 = no difficulty or absence of the disturbance and 5 = maximum difficulty or disturbance). Higher scores indicate more severe taste alterations.
5-Point Hedonic Rating Scale	Bi-weekly for 8 weeks	Taste Test Scale used to assessing liking or preference of taste of a product. Dislike Very Much: Assigned a value of 1, this represents strong disliking. Dislike Slightly: Assigned a value of 2, indicating mild disliking. Neither Like nor Dislike: Assigned a value of 3, representing a neutral response. Like Slightly: Assigned a value of 4, indicating mild liking. Like Very Much: Assigned a value of 5, representing strong liking. The higher the number scored indicates the participants enjoyed the taste vs the lower the number participant liked the taste less.

Secondary Outcome Measures

Name	Time	Method
Functional Oral Intake Scale (FOIS)	Bi-weekly for 8 weeks	Level of least restrictive diet- the higher the number the participant is able to eat by mouth the lesser of number the patient might be reliable on a feeding tube
M.D. Anderson Dysphagia Inventory (MDADI)	Bi-weekly for 8 weeks	Patient questionaire on swallow function. Scored on a scale score from 0 to 100. Lower the scores indicate a greater impact of dysphagia on the patients quality of life.