DysgeusiaNCT06311877
Effects of Flavor Modification for Management of Radiation Induced Dysgeusia
A study testing mBerry in people with Dysgeusia, run by University of South Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Dysgeusia
- What is being tested?
- mBerry
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2024to 14 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years
- Diagnosis of mandibular cancer, tonsillar cancer, and lingual cancer
- Receiving primary or adjuvant radiation therapy
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Flavor Modification for Management of Radiation Induced Dysgeusia in Head and Neck Cancer Patients
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.
Read the 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.
- Conditions
- Dysgeusia
- Being tested
- mBerry, No intervention
- Medical subject headings
- Dysgeusia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mBerryDietary supplement
mBerry tablets (.4 grams), which contain protein within the miracle berry called miraculin.
No interventionOther
The control group will not received intervention.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group given mBerry tablet | Experimental | 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. Receives: Dietary Supplement: mBerry |
| Control group not receiving mBerry | Active comparator | The control group will not be given a placebo. The control group will come to clinic for bi-weekly taste assessments. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-Point Hedonic Rating Scale
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.
Measured: Bi-weekly for 8 weeks
Chemotherapy-induced Taste Alteration Scale (CITAS)
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.
Measured: Bi-weekly for 8 weeks
Secondary outcomes (2)
M.D. Anderson Dysphagia Inventory (MDADI)
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.
Measured: Bi-weekly for 8 weeks
Functional Oral Intake Scale (FOIS)
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
Measured: Bi-weekly for 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start8 Sep 2024
- Primary completion14 Dec 2026 (estimated)
- Study completion14 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysgeusiaStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Larsson, University of South Florida
- Investigators
- Jennifer Larsson, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06311877
- Sponsor's protocol ID
- 6795
- Status last verified
- Apr 2025
- First submitted
- 6 Mar 2024
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Flavor Modification for Management of Radiation Induced Dysgeusia in Head and Neck Cancer Patients
- ClinicalTrials.gov ID
- NCT06311877
- Acronym / sponsor ID
- 6795
- Conditions
- Dysgeusia
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- 8 Sep 2024 (actual)
- Primary completion
- 14 Dec 2026 (estimated)
- Study completion
- 14 Apr 2027 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group given mBerry tablet | Experimental | Dietary Supplement: mBerryFor 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 | Active comparator | Other: No interventionThe control group will not be given a placebo. The control group will come to clinic for bi-weekly taste assessments. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 18 years
- Diagnosis of mandibular cancer, tonsillar cancer, and lingual cancer
- Receiving primary or adjuvant radiation therapy
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mBerrymBerry tablets (.4 grams), which contain protein within the miracle berry called miraculin. | Dietary supplement | Experimental group given mBerry tablet |
| No interventionThe control group will not received intervention. | Other | Control group not receiving mBerry |
Primary outcome
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.
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer Larsson principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mBerry in people with Dysgeusia, run by University of South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-Point Hedonic Rating Scale (time frame: Bi-weekly for 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.