What is the mechanism of action of this treatment?

Common treatments for taste dysfunction include the use of miracle fruit cubes, which alter taste perception by temporarily modifying taste receptors. This is achieved through miraculin, a glycoprotein that binds to taste buds and changes the way they perceive sour flavors, making them taste sweet. This mechanism is particularly important for patients undergoing treatments like radiation therapy for head and neck cancer, as it can help improve their taste function and overall quality of life during a period when taste alterations are common and difficult to manage.

What side effects are associated with this type of intervention?

Treatments for taste dysfunction, particularly those that alter taste perception by modifying taste receptors, have limited data on specific side effects. Clonazepam, used for persistent dysgeusia, can cause drowsiness, dizziness, and potential dependency. Treatments for underlying conditions, such as proton pump inhibitors for acid reflux, may cause headache, diarrhea, and abdominal pain. The side effects of treatments like the Miracle Fruit Cube, which temporarily modify taste receptors, are not well-documented.

What prior FDA approvals exist?

There are currently no FDA-approved treatments specifically for taste dysfunction that work by modifying taste receptors, similar to the mechanism of the Miracle Fruit Cube. Most interventions for taste dysfunction focus on managing underlying conditions or symptoms, but effective established interventions directly targeting taste alteration are lacking.

What other types of research exist?

Promising alternatives to Miracle Fruit Cube for taste dysfunction in 2024 include: 1) Zinc supplementation, which has been shown to improve taste perception in some patients. 2) Acupuncture, which has demonstrated benefits in managing symptoms related to taste dysfunction. 3) Glutamine supplementation, which may help in cases where taste dysfunction is related to chemotherapy-induced neuropathy. 4) Saliva substitutes and stimulants, which can help manage xerostomia and indirectly improve taste perception.

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Miraculin for Taste Dysfunction in Head and Neck Cancer Patients

Phase 3

Recruiting

Led By Sue Yom, MD, PhD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status <= 2 (Karnofsky >= 60%)

Age >=18 years at screening visit

Must not have

Inability to complete patient-reported outcomes (PROs) and quality of life questionnaires in English

Patient-reported pre-existing dysgeusia prior to beginning radiation therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

Pivotal Trial

Summary

This trial tests if miracle fruit cubes can help head and neck cancer patients undergoing radiation therapy by improving their sense of taste, making it easier for them to eat and maintain nutrition.

Who is the study for?

This trial is for adults over 18 with head and neck cancer, who can sign consent forms and have a performance status indicating they're mostly self-sufficient. They must be scheduled for radiation therapy, possibly with chemo, after surgery but cannot join if they had taste issues before treatment or rely on tube feeding.

What is being tested?

The study tests whether miraculin from miracle fruit can help patients undergoing radiation therapy maintain their sense of taste. Participants will receive either the miraculin cube or a placebo to see which one better prevents taste dysfunction during the first half of their treatment.

What are the potential side effects?

Since this trial involves a natural substance found in miracle fruit, side effects are expected to be minimal. However, participants may potentially experience allergic reactions due to sensitivity to berries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself but might not be able to do heavy physical work.

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I am 18 years old or older.

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I have a confirmed diagnosis of head and neck cancer and have undergone surgery including neck dissection.

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My treatment plan aims to cure my cancer and may include radiation therapy with or without chemotherapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot complete questionnaires in English.

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I had changes in taste before starting radiation therapy.

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I am getting my nutrition through a tube or IV before starting radiation therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Taste Assessment scores over time

Secondary study objectives

Change in Chemotherapy-induced taste alteration scale (CiTAS) scores over time

Change in Diet Diversity Scores over time

Change in EuroQol five-dimensional Questionnaire (EQ-5D) scores over time

+8 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Miracle FruitExperimental Treatment1 Intervention

Participants will receive 1 Miracle Fruit Farm miracle fruit cube by mouth three times a day before meals

Group II: Miracle Fruit PlaceboPlacebo Group1 Intervention

Participants will receive 1 placebo cube by mouth three times a day before meals

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for taste dysfunction include the use of miracle fruit cubes, which alter taste perception by temporarily modifying taste receptors. This is achieved through miraculin, a glycoprotein that binds to taste buds and changes the way they perceive sour flavors, making them taste sweet. This mechanism is particularly important for patients undergoing treatments like radiation therapy for head and neck cancer, as it can help improve their taste function and overall quality of life during a period when taste alterations are common and difficult to manage.

Self-perceived Taste and Flavor Perception: Associations With Quality of Life in Patients With Olfactory Loss.