A Study of Freeze-Dried Miracle Fruit (MiraBurst) on Participants Receiving Cancer Treatment

NCT07419581 | Not Yet Recruiting DMC

• 1 other identifier: CASE4Y25
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Dysgeusia; Solid Tumor

Keywords

Freeze-Dried Miracle Fruit; MiraBurst

Outcome Measures

Primary Outcomes (4)

• Evaluate effect on taste perception

  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.

  Baseline (Day 1), Day 7

• Evaluate effect on taste perception

  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.

  Baseline (Day 1), Day 28

• Evaluate effect on taste perception

  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.

  Baseline (Day 1), Day 90

• Evaluate effect on taste perception

  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.

  Baseline (Day 1), Day 120

Secondary Outcomes (8)

• Evaluate effect on weight

  Baseline (Day 1), Day 7

• Evaluate effect on weight

  Baseline (Day 1), Day 28

• Evaluate effect on weight

  Baseline (Day 1), Day 90

• Evaluate effect on weight

  Baseline (Day 1), Day 120

• Evaluate effect on quality of life

  Baseline (Day 1), Day 7

Study Arms (1)

MiraBurst

EXPERIMENTAL

Participants will consume one MiraBurst mini-square prior to each meal (up to four times per day) for a 90 day period.

Dietary Supplement: MiraBurst

Interventions

MiraBurst DIETARY_SUPPLEMENT

Participants will consume one 300 milligram (mg) MiraBurst mini-square prior to each meal (up to four times per day) for a 90 day period.

Also known as: Freeze-Dried Miracle Fruit

MiraBurst

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Related Publications (8)

• Kang 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 BACKGROUND

• Murtaza 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 BACKGROUND

• Komurcu 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 BACKGROUND

• Speck 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.

  BACKGROUND

• Hiroyuki 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 BACKGROUND

• Lopez-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 BACKGROUND

• 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

  BACKGROUND

• Satiroff MKWaBA. Pilot Study of

  BACKGROUND

MeSH Terms

Conditions

Dysgeusia

Condition Hierarchy (Ancestors)

Taste Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Shirley Thomas, MD, MRCP (UK), MRCP (UK) Pall Med, PGDip Pall Med

  Case Comprehensive Cancer Center, Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shirley Thomas, MD, MRCP (UK), MRCP (UK) Pall Med, PGDip Pall Med

CONTACT

216-445-0132; thomass75@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 19, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)