Using miracle fruit to improve taste in head and neck cancer patients undergoing 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
This study tests if miracle fruit can help improve taste for people with head and neck cancer who are getting radiation therapy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT05273307 on ClinicalTrials.gov |
What this trial studies
This Phase III clinical trial investigates the effectiveness of miracle fruit in alleviating taste dysfunction in patients with head and neck cancer receiving radiation therapy. Participants will be randomly assigned to receive either miracle fruit cubes or placebo cubes three times a day before meals during the initial phase of their treatment. The study aims to assess the impact of miracle fruit on dietary intake, weight changes, and overall quality of life, while also monitoring any treatment complications. The trial will follow participants for 60 days during treatment and an additional 180 days post-treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with confirmed head and neck cancer undergoing curative radiation therapy, with or without chemotherapy.
Not a fit: Patients who have pre-existing taste dysfunction or are receiving nutrition through tube feeds or intravenously prior to treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the quality of life for head and neck cancer patients by addressing taste dysfunction during radiation therapy.
How similar studies have performed: While taste dysfunction in cancer patients is a recognized issue, this specific approach using miracle fruit is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
San Francisco, California
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Sue Yom, MD, PhD — University of California, San Francisco
- Study coordinator: Brittany Liu
- Email: Brittany.Liu@ucsf.edu
- Phone: (415) 530-9815
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.