Addressing Taste Dysfunction With Miraculin in Head and Neck Cancer Patients Receiving Radiation Therapy: A Double-blinded, Placebo-controlled, Randomized Phase III Trial
University of California, San Francisco
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.
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 and neck cancer patients can reduce the effect of subjective taste alteration influence on dietary intake. SECONDARY OBJECTIVE: I. To characterize changes in weight, quality of nutritional intake, patient-reported taste dysfunction and quality of life, frequency of significant medical events or treatment complications, and association between oral cavity radiation dose and dysgeusia. Eligible p…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- Dietary SupplementMiraculin
Given orally
- Dietary SupplementMiracle Fruit Placebo Cube
Given orally
Location
- University of California, San FranciscoSan Francisco, California