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RecruitingPhase 3NCT05273307

Addressing Taste Dysfunction With Miraculin in Head and Neck Cancer Patients Receiving Radiation Therapy

Addressing Taste Dysfunction With Miraculin in Head and Neck Cancer Patients Receiving Radiation Therapy: A Double-blinded, Placebo-controlled, Randomized Phase III Trial

Sponsor

University of California, San Francisco

Enrollment

40 participants

Start Date

Mar 4, 2022

Study Type

INTERVENTIONAL

Conditions

Head and Neck CancerTaste Dysfunction

Summary

Patients diagnosed with head and neck cancer who receive radiation therapy with and without chemotherapy develop altered sense of taste due to treatment effect, which typically arises in the second week of radiation therapy and progresses throughout the course of treatment. While some symptoms such as pain, mucositis, and xerostomia can be managed with pain medications and saliva replacements, taste alteration has an earlier onset and is a more difficult symptom to readily address and intervene upon. There are no effective established interventions for taste, although this is a major issue in the patient experience. The investigator will be examining they hypothesis that a miracle fruit cube would yield the greatest benefit to improve taste dysfunction in the beginning half of radiation treatment when taste function is decreased but not absent.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a natural protein called miraculin — derived from a West African berry — can help head and neck cancer patients maintain their ability to taste food during radiation therapy, which often damages taste buds. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of head and neck cancer (throat, mouth, nose, sinuses, salivary gland, or related areas) - You are receiving radiation therapy with or without chemotherapy - You do not have a pre-existing taste problem before starting radiation - You are able to eat by mouth at the start of the study **You may NOT be eligible if...** - You already had a taste problem before starting radiation therapy - You are being fed through a tube or intravenously before the start of radiation - You are unable to complete the required questionnaires or follow-up assessments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTMiraculin

Given orally

DIETARY_SUPPLEMENTMiracle Fruit Placebo Cube

Given orally

Locations(1)

University of California, San Francisco

San Francisco, California, United States

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NCT05273307

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