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

Head and Neck Cancer Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

This is a Phase III, single-center, double-blinded, placebo-controlled, randomized controlled trial.

PRIMARY OBJECTIVE:

I. To determine if the use of miracle fruit during radiation therapy for head and neck cancer patients can reduce the effect of subjective taste alteration influence on dietary intake.

SECONDARY OBJECTIVE:

I. To characterize changes in weight, quality of nutritional intake, patient-reported taste dysfunction and quality of life, frequency of significant medical events or treatment complications, and association between oral cavity radiation dose and dysgeusia.

Eligible participants will be randomized in a one-to-one ratio prior to beginning radiation treatment into one of two study arms and will be stratified according to treatment with or without concurrent chemotherapy.

ARM 1: Participants will receive a commercially available food/natural product (Miracle Fruit Farm miracle fruit cube), 1 cube by mouth three times a day before meals

ARM 2: Participants will receive a Miracle Fruit Farm placebo cube, 1 cube by mouth three times a day before meals

Participants may continue study treatment for 60 days from the time of initiating treatment and will be followed post-treatment for 180 days. ;

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Taste Disorders

• NCT number: NCT05273307
• Study type: Interventional
• Source: University of California, San Francisco
• Contact: Jamese Johnson
• Phone: (415) 476-3048
• Email: Jamese.Johnson@ucsf.edu
• Status: Recruiting
• Phase: Phase 3
• Start date: March 4, 2022
• Completion date: April 30, 2025