Clinical trial NCT05273307: Addressing Taste Dysfunction With Miraculin in Head and Neck Cancer Patients Receiving Radiation Therapy
Official title: Addressing Taste Dysfunction With Miraculin in Head and Neck Cancer Patients Receiving Radiation Therapy: A Double-blinded, Placebo-controlled, Randomized Phase III Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Head and Neck Cancer
Taste Dysfunction
Keywords: Miracle Fruit
Placebo Controlled
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Miracle Fruit Farm
name: Mount Zion Health Fund
First posted: 2022-03-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Taste Assessment scores over time
timeFrame: 21 days
Secondary outcomes:
measure: Change in body weight over time
timeFrame: Up to 6 months
measure: Change in Diet Diversity Scores over time
timeFrame: Up to 6 months
measure: Change in Chemotherapy-induced taste alteration scale (CiTAS) scores over time
timeFrame: Up to 6 months
measure: Change in the Bernhardson Questionnaire scores over time
timeFrame: Up to 6 months
measure: Change in the European Organization for Research and Treatment of Head and Neck (EORTC QLQ-H&N35) scores over time
timeFrame: Up to 6 months
measure: Change in EuroQol five-dimensional Questionnaire (EQ-5D) scores over time
timeFrame: Up to 6 months
measure: Proportion of participants requiring percutaneous gastric tubes (PEG) over time
timeFrame: Up to 6 months
measure: Proportion of participants requiring hospital admission over time
timeFrame: Up to 6 months
measure: Number of participants who returned unused product
timeFrame: At 60 days
measure: Number of participants who returned weekly recall items
timeFrame: At 60 days
measure: Percentage of participants compliant with study treatment
timeFrame: At 60 days
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Sue Yom, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: