Head and Neck CancerPhase 3NCT05273307
Addressing Taste Dysfunction With Miraculin in Head and Neck Cancer Patients Receiving Radiation Therapy
A Phase 3 study testing Miraculin in people with Head and Neck Cancer and Taste Dysfunction, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Taste Dysfunction
- What is being tested?
- Miraculin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2022to 30 Nov 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
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
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.
Read the detailed description
This is a Phase III, single-center, double-blinded, placebo-controlled, randomized controlled trial.
PRIMARY OBJECTIVE:
- 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:
- 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.
- Conditions
- Head and Neck Cancer, Taste Dysfunction
- Being tested
- Miraculin, Miracle Fruit Placebo Cube
- Keywords
- Miracle Fruit, Placebo Controlled
- Medical subject headings
- Head and Neck Neoplasms, Taste Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiraculinDrug
Also called Miracle Fruit, Miracle Fruit Cube
Given orally
Miracle Fruit Placebo CubeDietary supplement
Also called Placebo
Given orally
| Study group | Role | What they receive |
|---|---|---|
| Miracle Fruit | Experimental | Participants will receive 1 Miracle Fruit Farm miracle fruit cube by mouth three times a day before meals Receives: Drug: Miraculin |
| Miracle Fruit Placebo | Placebo comparator | Participants will receive 1 placebo cube by mouth three times a day before meals Receives: Dietary Supplement: Miracle Fruit Placebo Cube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Taste Assessment scores over time
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.
Measured: Up to 6 months
Secondary outcomes (11)
Change in body weight over time
Participants weight will be measured over the course of the study to be used in assessing whether miracle fruit affects maintenance of nutritional status during treatment.
Measured: Up to 6 months
Change in Diet Diversity Scores over time
The Diet Diversity Score is a measure developed by the Food and Agriculture Organization of the United Nations as a rapid tool to assess nutrient adequacy of an individual's diet. The individual is asked to record all foods and drinks consumed in the previous day, which are then reviewed by the investigator and sorted into a list of nine food groups. The presence of a consumed food in a food group is assigned a score of one and if no food was consumed in a certain food group, then a score of zero is assigned. The individual Diet Diversity Score is then scored on a scale of 0-9 by adding the score from each food group. A higher score corresponds to higher diet diversity.
Measured: Up to 6 months
Change in Chemotherapy-induced taste alteration scale (CiTAS) scores over time
The CiTAS consists of an 18-item survey designed to evaluate four different domains of taste alteration: Decline in basic taste (5 items), discomfort (6 items) , phantogeusia and parageusia (3 items), and general taste alterations (4 items). Each item response score ranges from 1 = no difficulty or absence of the disturbance to 5 = maximum difficulty or disturbance. Scores for each domain can be calculated taking the cumulative score of all items within each domain and dividing by number of items with higher scores indicating a greater level of difficulty or disturbance.
Measured: Up to 6 months
Change in the Bernhardson Questionnaire scores over time
The Bernhardson Questionnaire is a two-item survey with assess taste and smell changed in chemotherapy patients and the impact it may have on quality of life. Each item is scored on a Likert scale of 1="not at all" to 4="very much", with an option of "N/A (no taste in change)". The total score is obtained by summing the item scores for a total of 8 possible with higher scores indicating a greater impact to quality of life.
Measured: Up to 6 months
Change in the European Organization for Research and Treatment of Head and Neck (EORTC QLQ-H&N35) scores over time
The EORTC QLQ-H\&N35 measures the impact symptoms experienced by head and neck cancer participants have on their quality of life. The head \& neck cancer module incorporates seven multi-item scales that assess pain, swallowing, senses (taste and smell), speech, social eating, social contact and sexuality. There are also eleven single items. The overall score consists of responses to the 35 items with responses ranging from 1="not at all" to 4="very much". The raw score is calculated by estimating the mean of each subscale with a resulting total range of 1-4. These scores are then transformed to standardized scale score, so that scores range from 0 to 100. A higher score indicates a lower quality of life.
Measured: Up to 6 months
Change in EuroQol five-dimensional Questionnaire (EQ-5D) scores over time
EQ-5D is a standardized instrument for measuring generic health status. The health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The respondents self-rate their level of severity for each dimension by selecting one of the following responses: no problems (0), slight problems (1), mild problems (2), moderate problems (3), or severe problems (4) with a particular dimension. Lower scores indicate less issues/problems with that particular health dimension.
Measured: Up to 6 months
Proportion of participants requiring percutaneous gastric tubes (PEG) over time
The proportion of participants who reported requiring the implementation of a PEG will be reported by treatment group over time.
Measured: Up to 6 months
Proportion of participants requiring hospital admission over time
The proportion of participants who require hospitalizations related to lack of nutrition or failure to thrive will be reported by treatment group over time.
Measured: Up to 6 months
Number of participants who returned unused product
Participants in each group will be requested to return any unused product at the end of treatment. The total number of participants who returned unused product during the treatment period will be reported by group.
Measured: At 60 days
Number of participants who returned weekly recall items
Participants in each group will be requested to answer a weekly recall item as too how compliant they were in taking the study product 3 times a day each day and return this survey at the end of treatment. The total number of participants who returned the weekly recall surveys during the treatment period will be reported by group.
Measured: At 60 days
Percentage of participants compliant with study treatment
Percent compliance by group will be calculated using the number of days on therapy divided by number of days should be on therapy multiplied by 100, using the weekly recall item and returning remaining study doses as verification of compliance.
Measured: At 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start4 Mar 2022
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Miracle Fruit Farm, Mount Zion Health Fund
- Responsible party
- Sponsor
- Investigators
- Sue Yom, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05273307
- Sponsor's protocol ID
- 22721
- Other IDs
- NCI-2022-01711
- Status last verified
- Aug 2026
- First submitted
- 1 Mar 2022
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05273307
- Acronym / sponsor ID
- 22721
- Conditions
- Head and Neck Cancer, Taste Dysfunction
- Keywords
- Miracle Fruit, Placebo Controlled
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Miracle Fruit Farm, Mount Zion Health Fund
- Study start
- 4 Mar 2022 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 10 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Miracle Fruit | Experimental | Drug: MiraculinParticipants will receive 1 Miracle Fruit Farm miracle fruit cube by mouth three times a day before meals |
| Miracle Fruit Placebo | Placebo comparator | Dietary Supplement: Miracle Fruit Placebo CubeParticipants will receive 1 placebo cube by mouth three times a day before meals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MiraculinAlso: Miracle Fruit, Miracle Fruit CubeGiven orally | Drug | Miracle Fruit |
| Miracle Fruit Placebo CubeAlso: PlaceboGiven orally | Dietary supplement | Miracle Fruit Placebo |
Primary outcome
Change in Taste Assessment scores over time
Time frame: Up to 6 months
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.
11 secondary outcomes
Change in body weight over time
Time frame: Up to 6 months
Change in Diet Diversity Scores over time
Time frame: Up to 6 months
Change in Chemotherapy-induced taste alteration scale (CiTAS) scores over time
Time frame: Up to 6 months
Change in the Bernhardson Questionnaire scores over time
Time frame: Up to 6 months
Change in the European Organization for Research and Treatment of Head and Neck (EORTC QLQ-H&N35) scores over time
Time frame: Up to 6 months
Change in EuroQol five-dimensional Questionnaire (EQ-5D) scores over time
Time frame: Up to 6 months
Proportion of participants requiring percutaneous gastric tubes (PEG) over time
Time frame: Up to 6 months
Proportion of participants requiring hospital admission over time
Time frame: Up to 6 months
Number of participants who returned unused product
Time frame: At 60 days
Number of participants who returned weekly recall items
Time frame: At 60 days
Percentage of participants compliant with study treatment
Time frame: At 60 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sue Yom, MD, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Miraculin in people with Head and Neck Cancer and Taste Dysfunction, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Taste Assessment scores over time (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.