Effects of Flavor Modification for Management of Radiation Induced Dysgeusia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: mBerry, No intervention.
- Who it may be relevant to
- Registry conditions: Dysgeusia. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Flavor Modification for Management of Radiation Induced Dysgeusia in Head and Neck Cancer Patients
Overview
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.
Interventions
- 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.
Primary outcome measures
- 5-Point Hedonic Rating Scale [Time frame: Bi-weekly for 8 weeks]
- Chemotherapy-induced Taste Alteration Scale (CITAS) [Time frame: Bi-weekly for 8 weeks]
Secondary outcome measures (2)
- M.D. Anderson Dysphagia Inventory (MDADI) [Time frame: Bi-weekly for 8 weeks]
- Functional Oral Intake Scale (FOIS) [Time frame: Bi-weekly for 8 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of South Florida — Tampa
Identifiers
NCT: NCT06311877 · 6795