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Enrolling by Invitation

NCT Number: NCT06311877

Effects of Flavor Modification for Management of Radiation Induced Dysgeusia

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.

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Key information

Conditions

Dysgeusia Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Taste Disorders

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of South Florida

Tampa, Florida, 33606, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

mBerry

Dietary Supplement

mBerry tablets (.4 grams), which contain protein within the miracle berry called miraculin.

No intervention

Other

The control group will not received intervention.

Primary outcomes

  1. 5-Point Hedonic Rating Scale

    Time frame: 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.

  2. Chemotherapy-induced Taste Alteration Scale (CITAS)

    Time frame: 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.

Secondary outcomes

  1. M.D. Anderson Dysphagia Inventory (MDADI)

    Time frame: 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.

  2. Functional Oral Intake Scale (FOIS)

    Time frame: 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

Other outcomes

  1. Patients weight measurement

    Time frame: Patients will be seen for 4 follow-up appointments in the 8 week time frame of the study. The patient will be weighed at the 1st and 4th follow-up visit.

    Weight

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Mar 15, 2024
Registry last updated
Apr 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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