Status:
RECRUITING
Addressing Taste Dysfunction With Miraculin in Head and Neck Cancer Patients Receiving Radiation Therapy
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Miracle Fruit Farm
Mount Zion Health Fund
Conditions:
Head and Neck Cancer
Taste Dysfunction
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 we...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
March 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05273307
Start Date
March 4 2022
End Date
September 30 2026
Last Update
September 22 2025
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94143