Addressing Taste Dysfunction With Miraculin in Head and Neck Cancer Patients Receiving Radiation Therapy
Running, not enrolling · Phase 3 · Has a placebo group
Conditions studied: Head and Neck Cancer, Taste Dysfunction
In brief
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 facts
- Study ID
- NCT05273307
- Run by
- University of California, San Francisco
- People needed
- 40
- Starts
- 2022-03-04
- Expected to finish
- 2026-11-30
- Last updated by the study team
- 2026-06-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- University of California, San Francisco — San Francisco, California, United States
Full record on ClinicalTrials.gov
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