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

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT05273307
Phase
PHASE3
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Miraculin — DIETARY_SUPPLEMENT
    Given orally
  • Miracle Fruit Placebo Cube — DIETARY_SUPPLEMENT
    Given orally

Study Details

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.

Key Dates

Start date
Mar 4, 2022
Status verified
Sep 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Miracle Fruit
    Participants will receive 1 Miracle Fruit Farm miracle fruit cube by mouth three times a day before meals
  • Placebo Comparator: Miracle Fruit Placebo
    Participants will receive 1 placebo cube by mouth three times a day before meals

Primary Outcome Measure

Change in Taste Assessment scores over time [ Time Frame: 21 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
Brittany Liu
415-530-9815
877-827-3222
Sue Yom, MD, PhD (PRINCIPAL_INVESTIGATOR)

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