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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

Study Summary

This trial is testing whether a miracle fruit cube can help improve taste dysfunction in people with head and neck cancer who are receiving radiation therapy.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Taste Assessment scores over time

Secondary outcome measures

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

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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Miracle Fruit FarmUNKNOWN

University of California, San FranciscoLead Sponsor

2,506 Previous Clinical Trials

15,238,515 Total Patients Enrolled

Mount Zion Health FundOTHER

12 Previous Clinical Trials

918 Total Patients Enrolled

Media Library

Miraculin Clinical Trial Eligibility Overview. Trial Name: NCT05273307 — Phase 3

Taste Dysfunction Research Study Groups: Miracle Fruit Placebo, Miracle Fruit

Taste Dysfunction Clinical Trial 2023: Miraculin Highlights & Side Effects. Trial Name: NCT05273307 — Phase 3

Miraculin 2023 Treatment Timeline for Medical Study. Trial Name: NCT05273307 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are the most that can enroll in this test?

"Yes, the data on clinicaltrials.gov suggests that this study is actively looking for candidates. The study was first posted on 3/4/2022 and was last edited on 6/27/2022. The study is enrolling 40 participants at 1 sites."

Answered by AI

Has the Federal Drug Administration cleared Miraculin for public consumption?

"There is already some clinical evidence in support of Miraculin's efficacy, as well as data from multiple rounds of safety testing, so it received a score of 3."

Answered by AI

Are we still taking people in for this experiment?

"That is correct, the clinical trial mentioned is currently recruiting patients. It was posted on March 4th, 2020 and last updated June 27th, 2020. The study needs 40 participants from 1 site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Addressing Taste Dysfunction With Miraculin in Head and Neck Cancer Patients Receiving Radiation Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05273307.