mBerry for Taste Disturbance

Overseen ByAshley Traeger

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of South Florida

Must not be taking: Metformin

Disqualifiers: Diabetes, Prediabetes, Glossectomy, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are taking Metformin, you cannot participate.

What data supports the effectiveness of the treatment mBerry for taste disturbance?

Some studies suggest that zinc therapy can help improve taste disturbances, with about one-third of patients responding to it. While mBerry is not zinc, this indicates that certain treatments can aid in taste recovery, especially when taste is affected by deficiencies or disturbances.¹ ² ³ ⁴ ⁵

How does the treatment mBerry differ from other treatments for taste disturbance?

mBerry is unique because it uses natural compounds to alter taste perception, potentially making bitter foods taste sweet, which is different from traditional treatments that may not address taste perception directly.⁶ ⁷ ⁸ ⁹ ¹⁰

What is the purpose of this trial?

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.

Research Team

Jennifer Larsson

Principal Investigator

University of South Florida

Eligibility Criteria

This trial is for adults over 18 with mandibular, tonsillar, or lingual cancer who are undergoing primary or adjuvant radiation therapy. It's designed to help those experiencing taste disturbances (dysgeusia) due to their treatment.

Inclusion Criteria

I am over 18 years old.

I have been diagnosed with cancer in my jaw, tonsils, or tongue.

I am currently undergoing radiation therapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants undergo radiation therapy as part of their standard cancer treatment

Varies

Treatment

Participants receive mBerry tablets twice daily for 8 weeks to manage dysgeusia

8 weeks

Bi-weekly taste assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

mBerry

Trial Overview The study tests the effects of mBerry on managing dysgeusia in head and neck cancer patients receiving radiation. Participants will either use mBerry or receive no intervention to see if it improves life quality and nutritional outcomes.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Experimental group given mBerry tabletExperimental Treatment1 Intervention

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.

Group II: Control group not receiving mBerryActive Control1 Intervention

The control group will not be given a placebo. The control group will come to clinic for bi-weekly taste assessments.