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

Who is this study for? Patients with Head and Neck Cancer, Taste Dysfunction
What treatments are being studied? Miraculin
Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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

Locations
United States
California
University of California, San Francisco
RECRUITING
San Francisco
Contact Information
Primary
Brittany Liu
Brittany.Liu@ucsf.edu
(415) 530-9815
Time Frame
Start Date: 2022-03-04
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 40
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: University of California, San Francisco
Collaborators: Mount Zion Health Fund, Miracle Fruit Farm

This content was sourced from clinicaltrials.gov