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

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · Mar 1, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating how a special fruit cube, made from a miracle fruit, can help improve taste issues in patients with head and neck cancer who are undergoing radiation therapy. Many of these patients experience changes in their sense of taste, which can begin around the second week of treatment and worsen over time. While there are ways to manage other symptoms like pain and dry mouth, taste changes are harder to address, and currently, there are no effective treatments for this problem. The researchers believe that using these fruit cubes early in the radiation treatment may enhance taste function when it is still somewhat present.

To participate in this trial, individuals must be at least 18 years old and have a confirmed diagnosis of head and neck cancer that requires radiation therapy. They should not have had taste issues before starting their treatment and should not be receiving nutrition through tubes. Participants will be asked to complete questionnaires about their experiences and quality of life. The trial is open to everyone, regardless of gender, and aims to provide valuable insights into improving the quality of life for patients dealing with taste dysfunction during their cancer treatment.

Gender

ALL

Eligibility criteria

• 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.