This phase III trial tests whether miraculin, also called “Miracle Fruit,” works in improving taste dysfunction in patients with head and neck cancer receiving radiation therapy. When patients with head and neck cancer receive radiation therapy, the treatment may cause a change in sense of taste. Foods and drinks may taste unpleasant, or not as flavorful. This side effect is called “dysgeusia.” Dysgeusia can lead to loss of appetite, which may cause health issues such as dehydration and weight loss. Miracle Fruit alters sense of taste by making sour things taste sweet. A component of Miracle Fruit, called “miraculin,” is what causes this change. Giving miraculin to patients with head and neck cancer receiving radiation therapy may help alleviate dysgeusia and decrease medical problems such as weight loss, dehydration, and lack of nutrition.
Additional locations may be listed on ClinicalTrials.gov for NCT05273307.
Locations matching your search criteria
United States
California
San Francisco
University of California San FranciscoStatus: Active
Contact: Sue Sun Yom
Phone: 415-353-7175
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 OBJECTIVES:
I. To evaluate changes in weight.
II. To evaluate changes in quality of nutritional intake.
III. To evaluate changes in patient-reported taste dysfunction.
IV. To evaluate changes in taste-related quality of life.
V. To evaluate changes in frequency of significant medical events or treatment complications.
VI. To evaluate association between oral cavity radiation dose and changes in dysgeusia.
OUTLINE: Patients are randomized in 1 of 2 arms.
ARM I: Patients receive miraculin orally (PO) three times daily (TID) before each meal for 7 weeks.
ARM II: Patients receive placebo PO TID before each meal for 7 weeks.
After completion of study treatment, patients are followed up at 3 and 6 months after completion of radiation therapy.
Trial PhasePhase III
Trial Typesupportive care
Lead OrganizationUniversity of California San Francisco
Principal InvestigatorSue Sun Yom