RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2022-03-04
Study Completion:2026-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05273307

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. 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.
  2. 2. Treatment plan includes curative-intent (including post-operative) radiation therapy with or without concurrent chemotherapy
  3. 3. Age \>=18 years at screening visit.
  4. 4. Eastern Cooperative Oncology Group (ECOG) performance status \<= 2 (Karnofsky \>= 60%)
  5. 5. Ability to understand a written informed consent document, and the willingness to sign it
  1. 1. Patient-reported pre-existing dysgeusia prior to beginning radiation therapy.
  2. 2. Receiving nutrition through tube feeds or intravenously prior to beginning radiation therapy.
  3. 3. Inability to complete patient-reported outcomes (PROs) and quality of life questionnaires in English.
  4. 4. Known allergy to berries.

Contacts and Locations

Study Contact

Jamese Johnson
CONTACT
(415) 476-3048
Jamese.Johnson@ucsf.edu

Principal Investigator

Sue Yom, MD, PhD
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

University of California, San Francisco
San Francisco, California, 94143
United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

  • Sue Yom, MD, PhD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-04
Study Completion Date2026-04-30

Study Record Updates

Study Start Date2022-03-04
Study Completion Date2026-04-30

Terms related to this study

Keywords Provided by Researchers

  • Miracle Fruit
  • Placebo Controlled

Additional Relevant MeSH Terms

  • Head and Neck Cancer
  • Taste Dysfunction