Addressing Taste Dysfunction With Miraculin in Head and Neck Cancer Patients Receiving Radiation Therapy: A Double-blinded, Placebo-controlled, Randomized Phase III Trial
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Head and Neck Cancer
- Sponsor
- University of California, San Francisco
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Change in Taste Assessment scores over time
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
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 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.
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 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 participants will be randomized in a one-to-one ratio prior to beginning radiation treatment into one of two study arms and will be stratified according to treatment with or without concurrent chemotherapy. ARM 1: Participants will receive a commercially available food/natural product (Miracle Fruit Farm miracle fruit cube), 1 cube by mouth three times a day before meals ARM 2: Participants will receive a Miracle Fruit Farm placebo cube, 1 cube by mouth three times a day before meals Participants may continue study treatment for 60 days from the time of initiating treatment and will be followed post-treatment for 180 days.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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.
Outcomes
Primary Outcomes
Change in Taste Assessment scores over time
Time Frame: 21 days
The Taste Assessment is a two-item questionnaire used to determine the overall experiences of the participant taste sensation in the past 7 days; with one item asking about taste alteration and another asking about the interference of taste alteration with dietary intake. Scores for each item are obtained by responses to a Likert scale ranging from 1= "not at all" to 5="a lot", with greater scores indicating a greater taste alteration or interference.
Secondary Outcomes
- Change in the European Organization for Research and Treatment of Head and Neck (EORTC QLQ-H&N35) scores over time(Up to 6 months)
- Change in body weight over time(Up to 6 months)
- Change in Diet Diversity Scores over time(Up to 6 months)
- Change in Chemotherapy-induced taste alteration scale (CiTAS) scores over time(Up to 6 months)
- Change in the Bernhardson Questionnaire scores over time(Up to 6 months)
- Change in EuroQol five-dimensional Questionnaire (EQ-5D) scores over time(Up to 6 months)
- Proportion of participants requiring percutaneous gastric tubes (PEG) over time(Up to 6 months)
- Proportion of participants requiring hospital admission over time(Up to 6 months)
- Number of participants who returned unused product(At 60 days)
- Number of participants who returned weekly recall items(At 60 days)
- Percentage of participants compliant with study treatment(At 60 days)