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

RECRUITINGPhase 3Sponsored by University of California, San Francisco
Actively Recruiting
PhasePhase 3
SponsorUniversity of California, San Francisco
Started2022-03-04
Est. completion2026-09-30
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site

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

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

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. Treatment plan includes curative-intent (including post-operative) radiation therapy with or without concurrent chemotherapy
3. Age \>=18 years at screening visit.
4. Eastern Cooperative Oncology Group (ECOG) performance status \<= 2 (Karnofsky \>= 60%)
5. Ability to understand a written informed consent document, and the willingness to sign it

Exclusion Criteria:

1. Patient-reported pre-existing dysgeusia prior to beginning radiation therapy.
2. Receiving nutrition through tube feeds or intravenously prior to beginning radiation therapy.
3. Inability to complete patient-reported outcomes (PROs) and quality of life questionnaires in English.
4. Known allergy to berries.

Conditions3

CancerHead and Neck CancerTaste Dysfunction

Locations1 site

University of California, San Francisco
San Francisco, California, 94143
Brittany Liu415-530-9815Brittany.Liu@ucsf.edu

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