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

NCT05273307 | Active Not Recruiting Phase 3 DMC

• 2 other identifiers: 22721NCI-2022-01711
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Head and Neck Cancer; Taste Dysfunction

Keywords

Miracle Fruit; Placebo Controlled

Outcome Measures

Primary Outcomes (1)

• Change in Taste Assessment scores over time

  The Taste Assessment is a two-item questionnaire used to determine the overall experiences of the participant taste sensation in the past 7 days; with one item asking about taste alteration and another asking about the interference of taste alteration with dietary intake. Scores for each item are obtained by responses to a Likert scale ranging from 1= "not at all" to 5="a lot", with greater scores indicating a greater taste alteration or interference.

  Up to 6 months

Secondary Outcomes (11)

• Change in body weight over time

  Up to 6 months

• Change in Diet Diversity Scores over time

  Up to 6 months

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

  Up to 6 months

• Change in the Bernhardson Questionnaire scores over time

  Up to 6 months

• Change in the European Organization for Research and Treatment of Head and Neck (EORTC QLQ-H&N35) scores over time

  Up to 6 months

Study Arms (2)

Miracle Fruit

EXPERIMENTAL

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

Dietary Supplement: Miraculin

Miracle Fruit Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Miracle Fruit Placebo Cube

Interventions

Miraculin DIETARY_SUPPLEMENT

Given orally

Also known as: Miracle Fruit, Miracle Fruit Cube

Miracle Fruit

Miracle Fruit Placebo Cube DIETARY_SUPPLEMENT

Given orally

Also known as: Placebo

Miracle Fruit Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have documentation of histologically or cytologically confirmed head and neck cancer diagnosis including primary tumors of the following sites: oropharynx, nasopharynx, oral cavity, nasal cavity, paranasal sinus, salivary gland, unknown primary origin in the head and neck, or cutaneous squamous cell carcinoma having had a surgery including neck dissection.
• Treatment plan includes curative-intent (including post-operative) radiation therapy with or without concurrent chemotherapy
• Age \>=18 years at screening visit.
• Eastern Cooperative Oncology Group (ECOG) performance status \<= 2 (Karnofsky \>= 60%)
• Ability to understand a written informed consent document, and the willingness to sign it

You may not qualify if:

• Patient-reported pre-existing dysgeusia prior to beginning radiation therapy.
• Receiving nutrition through tube feeds or intravenously prior to beginning radiation therapy.
• Inability to complete patient-reported outcomes (PROs) and quality of life questionnaires in English.
• Known allergy to berries.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Miracle Fruit Farm: collaborator
• Mount Zion Health Fund: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Taste Disorders

Interventions

miraculin protein, Synsepalum dulcificum

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sue Yom, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Packaging and labeling of test and control treatments will be identical and performed by Miracle Fruit Farm to maintain blinding conditions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2022
• First Posted: March 10, 2022
• Study Start: March 4, 2022
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)