Effects of Flavor Modification for Management of Radiation Induced Dysgeusia

Part of paid clinical trials in Tampa, Florida.

Sponsor
University of South Florida
Study ID
NCT06311877
Status
Enrolling By Invitation

Conditions

  • Dysgeusia

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • mBerry — DIETARY_SUPPLEMENT
    mBerry tablets (.4 grams), which contain protein within the miracle berry called miraculin.
  • No intervention — OTHER
    The control group will not received intervention.

Study Details

Intervention for dysgeusia in head and neck cancer patients undergoing radiation therapy. This research proposal aims to investigate potential benefits of mBerry in improving quality of life and nutritional outcome in head and neck cancer patients' post-radiation therapy. Our hypothesis is that cancer patients undergoing radiation therapy will benefit from use of miracle berry in treatment of dysgeusia.

Key Dates

Start date
Sep 8, 2024
Status verified
Apr 2025
Primary completion
Dec 14, 2026
Completion
Apr 14, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental group given mBerry tablet
    For the experiment group, the clinician will be providing participant with daily 0.4 gram mBerry tablets (total of 112 tablets) to consume twice a day (for two meals) over an 8-week period. The participant will be provided with a log form to track mBerry use for the two meals each day for the 8-week period. They will be requested to bring log to each of the clinical visits which include bi-weekly taste assessments.
  • Active Comparator: Control group not receiving mBerry
    The control group will not be given a placebo. The control group will come to clinic for bi-weekly taste assessments.

Primary Outcome Measure

5-Point Hedonic Rating Scale [ Time Frame: Bi-weekly for 8 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of South FloridaTampaFlorida33606-

Find similar trials in Tampa, FL

By research site
University of South Florida· Tampa, FL

Related Studies