Clinical trial · Interventional
Addressing Taste Dysfunction With Miraculin in Head and Neck Cancer Patients Receiving Radiation Therapy
Addressing Taste Dysfunction With Miraculin in Head and Neck Cancer Patients Receiving Radiation Therapy: A Double-blinded, Placebo-controlled, Randomized Phase III Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Taste Dysfunction | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Miracle Fruit Placebo Cube | Dietary Supplement | — | UNRESOLVED |
| Miraculin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Miracle Fruit
- description
- Participants will receive 1 Miracle Fruit Farm miracle fruit cube by mouth three times a day before meals
- interventionNames
- Drug: Miraculin
- type
- PLACEBO_COMPARATOR
- label
- Miracle Fruit Placebo
- description
- Participants will receive 1 placebo cube by mouth three times a day before meals
- interventionNames
- Dietary Supplement: Miracle Fruit Placebo Cube
Primary outcomes (1)
- measure
- Change in Taste Assessment scores over time
- timeFrame
- Up to 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available