Clinical trial · Interventional
A Study of Freeze-Dried Miracle Fruit (MiraBurst) on Participants Receiving Cancer Treatment
A Pilot Study to Explore the Effects of Freeze-Dried Miracle Fruit (MiraBurst) on Patients Receiving Cancer Treatment
NCT07419581CI-TRIAL-00109976not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study is for people with a diagnosis of solid tumor cancer who are experiencing changes in taste perception due to cancer treatment. Changes in taste perception, also known as dysgeusia, is a frequent side effect of cancer treatment and can significantly impacts quality of life. These alterations may be temporary or, in some cases, permanent. The purpose of this study is determine whether freeze dried miracle fruit, marketed as MiraBurst can improve taste perception in this group of people. Participants involved in this study will be asked to take one MiraBurst mini-square upto four times a day, prior to eating, for 90 days.
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 |
|---|---|---|---|
| Dysgeusia | — | UNRESOLVED | — |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MiraBurst | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MiraBurst
- description
- Participants will consume one MiraBurst mini-square prior to each meal (up to four times per day) for a 90 day period.
- interventionNames
- Dietary Supplement: MiraBurst
Primary outcomes (4)
- measure
- Evaluate effect on taste perception
- timeFrame
- Baseline (Day 1), Day 7
- description
- Taste changes will be assessed using the Chemotherapy-induced Taste Alteration Scale-English version (CiTAS-E) questionnaire. The CiTAS questionnaire is composed of 18 items. Six questions are answered on a 5-point Likert scale from 1 (Taste normal) to 5 (Unable to taste at all). Twelve questions are answered on a 5-point Likert scale from 1 (No) to 5 (Very). The items are divided into three dimensions: 1) quantitative changes in the perception of flavors (hypogeusia, ageusia), 2) qualitative changes in the perception of flavors (i.e., heterogeusia, cacogeusia), and 3) problems related to nutrition (i.e., difficulty in eating hot or fat foods). CITAS questionnaire does not include open-ended qualitative questions. They are closed ended questions which participants rate. Higher scores indicate worse symptoms.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years and above * Solid tumor cancer diagnosis * Participants on active cancer treatment * Eastern Cooperative Oncology Group (ECOG) score of 0 to 2 * Grade 2 dysgeusia related to cancer treatment per Common Terminology Criteria for Adverse Events (CTCAE) version 6.0 Exclusion Criteria: * Grade 2 dysgeusia prior to starting cancer treatment * Participants with severe dementia, severe neurological illness who are unable to understand the study or provide informed consent * Participants on enteral and parenteral nutrition * Participants with eating disorders * Pregnancy * Participants with uncontrolled acute medical issues (e.g., acute angina, acute stroke, uncontrolled diabetes mellitus, uncontrolled hypertension etc.) that, per investigator's assessment, would contraindicate the study treatment
References
Publications (8)
- BACKGROUNDKang D, Kim S, Kim H, Lee M, Kong SY, Chang YJ, Sim SH, Kim YJ, Cho J. Surveillance of Symptom Burden Using the Patient-Reported Outcome Version of the Common Terminology Criteria for Adverse Events in Patients With Various Types of Cancers During Chemoradiation Therapy: Real-World Study. JMIR Public Health Surveill. 2023 Mar 8;9:e44105. doi: 10.2196/44105. PMID 36884274
- BACKGROUNDMurtaza B, Hichami A, Khan AS, Ghiringhelli F, Khan NA. Alteration in Taste Perception in Cancer: Causes and Strategies of Treatment. Front Physiol. 2017 Mar 8;8:134. doi: 10.3389/fphys.2017.00134. eCollection 2017. PMID 28337150
- BACKGROUNDKomurcu S, Nelson KA, Walsh D, Ford RB, Rybicki LA. Gastrointestinal symptoms among inpatients with advanced cancer. Am J Hosp Palliat Care. 2002 Sep-Oct;19(5):351-5. doi: 10.1177/104990910201900513. PMID 12269782
- BACKGROUNDSpeck RM, DeMichele A, Farrar JT, Hennessy S, Mao J, Stineman MG, Barg FK. Coping with the burden of taste alteration, a toxicity of taxane-based chemotherapy. J Clin Oncol. 2012;30(15). PubMed PMID: WOS:000318009801842.
- BACKGROUNDHiroyuki Otani, Amano K, Morita T, Miura T, Mori N, Tatara R, Kessoku T, Matsuda Y, Tagami K, Mori M, Taniyama T, Nakajima N, Nakanishi E, Kako J, Shirado AN, Yokomichi N, Miyashita M. Impact of taste/smell disturbances on dietary intakes and cachexia-related quality of life in patients with advanced cancer. Support Care Cancer. 2023 Jan 30;31(2):141. doi: 10.1007/s00520-023-07598-6. PMID 36715776
- BACKGROUNDLopez-Plaza B, Alvarez-Mercado AI, Arcos-Castellanos L, Plaza-Diaz J, Ruiz-Ojeda FJ, Brandimonte-Hernandez M, Feliu-Batlle J, Hummel T, Gil A, Palma-Milla S. Efficacy and Safety of Habitual Consumption of a Food Supplement Containing Miraculin in Malnourished Cancer Patients: The CLINMIR Pilot Study. Nutrients. 2024 Jun 17;16(12):1905. doi: 10.3390/nu16121905. PMID 38931260
- H. P. Soares MC, M. A. Schwartz, J. F. Pizzolato, J. Lutzky, R. J. Campbell, J. L. Beaumont, D. Eton, S. Stonick, and R. Lilenbaum. Treatment of taste alterations in chemotherapy patients using the "miracle fruit": preliminary analysis of a pilot study. American Society of Clinical Oncology. 2010