DysgeusiaNCT07419581
A Study of Freeze-Dried Miracle Fruit (MiraBurst) on Participants Receiving Cancer Treatment
A study testing MiraBurst in people with Dysgeusia and Solid Tumor, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysgeusia, Solid Tumor
- What is being tested?
- MiraBurst
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Shirley Thomas, MD, MRCP (UK), MRCP (UK) Pall Med, PGDip Pall Med contact
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Shirley Thomas, MD MRCP (UK), MRCP (UK) Pall Med, PGDip Pall Med, 216-445-0132, thomass75@ccf.org
Shirley Thomas, MD MRCP (UK), MRCP (UK) Pall Med, PGDip Pall Med
About this study
Official title: A Pilot Study to Explore the Effects of Freeze-Dried Miracle Fruit (MiraBurst) on Patients Receiving Cancer Treatment
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.
Read the detailed description
Cancer and the treatment of cancer can create many symptoms that impact people's lives. More than 90% of people with cancer have at least one symptom caused by their cancer or treatment. The most common symptoms are related to the gastrointestinal system. Change in sense of taste is the fourth most common symptom and may be described as "food not tasting the same as they use to, food tasting bland, everything tastes the same, or an unpleasant bitter or metallic taste." Change in taste can impact a person's quality of life, but there are not many options to treat this symptom.
The MiraBurst product used in this study comes from a berry fruit harvested in Ghana. The berries are freeze-dried into a powder and pressed into small, square pieces that each weigh 300 mg. The product is made from 100% pure miracle berry powder and has the same natural composition as the fresh berry. It contains no additives or preservatives. The berry is vegan, allergen-free, and gluten-free, and it has no known side effects. During processing, no substances are extracted from the berries except water. This product is not classified as a drug or a dietary supplement and does not contain any active or inactive ingredients. Because it is a pure berry powder, it does not go through a strict standardization process. Both the raw freeze-dried powder and the finished product (MiraBurst Mini Squares) are tested by third-party laboratories for microbial safety in both Ghana and the United States. The powder is also tested for heavy metals and goes through contaminant removal and metal detection during manufacturing. According to the manufacturer, the freeze-dried miracle berry powder is produced in a Good Manufacturing Practice (GMP)-compliant facility in Ghana. The manufacturing and packaging facilities for MiraBurst Mini Squares in the United States (Connecticut and New Jersey) are also GMP-compliant. There are no known interactions between this product and herbs or medications. The product is available over the counter and is commonly used several times a day, up to five times daily-before breakfast, snacks, lunch, and dinner.
Previous studies have shown that supplements made from the same miracle fruit can have promising effects for people with cancer. One pilot study in 2010 found that 30% of people who received miracle fruit for two weeks reported improvements in their taste perception. In another pilot study, all participants who received miracle fruit reported positive changes after two weeks. Participants reported that taste changes such as experiencing a sour or metallic taste improved and that foods tasted sweeter or more pleasant. Yet another study found these similar positive changes, while also finding that participants who received miracle berry also had a higher energy intake, increased fat-free mass, and improved quality of life compared to participants on placebo. Preclinical data on miracle berry extract indicate that it is relatively safe, with no significant toxicity reported. The active component in miracle berry, miraculin, is a glycoprotein that is rapidly and completely digested in the gastrointestinal (GI) tract. This makes systemic absorption and interaction with drug-metabolizing enzymes, such as CYP450 or MAO (monoamine oxidase), highly unlikely. Both in silico and in vitro analyses have demonstrated a low potential for allergenicity or cross-reactivity with other proteins.
This study seeks to confirm the promising and beneficial effects of miracle fruit, with a branded product (MiraBurst), which has appropriate manufacturing controls in place for quality consistency, on symptoms related to dysgeusia (alterations in taste perception).
- Conditions
- Dysgeusia, Solid Tumor
- Being tested
- MiraBurst
- Keywords
- Freeze-Dried Miracle Fruit, MiraBurst
- Medical subject headings
- Dysgeusia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiraBurstDietary supplement
Also called Freeze-Dried Miracle Fruit
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.
| Study group | Role | What they receive |
|---|---|---|
| MiraBurst | Experimental | Participants will consume one MiraBurst mini-square prior to each meal (up to four times per day) for a 90 day period. Receives: Dietary Supplement: MiraBurst |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Day 1), Day 120
Secondary outcomes (8)
Evaluate effect on weight
Change in weight will be quantified as an absolute number change from baseline (in pounds (lbs)), as well as a percent change from baseline.
Measured: Baseline (Day 1), Day 7
Evaluate effect on weight
Change in weight will be quantified as an absolute number change from baseline (in pounds (lbs)), as well as a percent change from baseline.
Measured: Baseline (Day 1), Day 28
Evaluate effect on weight
Change in weight will be quantified as an absolute number change from baseline (in pounds (lbs)), as well as a percent change from baseline.
Measured: Baseline (Day 1), Day 90
Evaluate effect on weight
Change in weight will be quantified as an absolute number change from baseline (in pounds (lbs)), as well as a percent change from baseline.
Measured: Baseline (Day 1), Day 120
Evaluate effect on quality of life
Quality of Life will be assessed using the FAACT (functional assessment of anorexia/cachexia therapy) questionnaire. The FAACT questionnaire contains 40 items that measure four primary domains of global QoL along with specific anorexia/cachexia-related QoL issues. Physical well-being, social/family well-being, emotional well-being, and functional well-being comprise the four core measures of QoL, with an additional 12-item subscale evaluation of nutritional QoL. Items are answered on a 5-point Likert scale from 0 (Not at all) to 4 (Very much). The global scores are calculated by summing the scores of the five individual QoL domains; higher scores indicate better quality of life.
Measured: Baseline (Day 1), Day 7
Evaluate effect on quality of life
Quality of Life will be assessed using the FAACT (functional assessment of anorexia/cachexia therapy) questionnaire. The FAACT questionnaire contains 40 items that measure four primary domains of global QoL along with specific anorexia/cachexia-related QoL issues. Physical well-being, social/family well-being, emotional well-being, and functional well-being comprise the four core measures of QoL, with an additional 12-item subscale evaluation of nutritional QoL. Items are answered on a 5-point Likert scale from 0 (Not at all) to 4 (Very much). The global scores are calculated by summing the scores of the five individual QoL domains; higher scores indicate better quality of life.
Measured: Baseline (Day 1), Day 28
Evaluate effect on quality of life
Quality of Life will be assessed using the FAACT (functional assessment of anorexia/cachexia therapy) questionnaire. The FAACT questionnaire contains 40 items that measure four primary domains of global QoL along with specific anorexia/cachexia-related QoL issues. Physical well-being, social/family well-being, emotional well-being, and functional well-being comprise the four core measures of QoL, with an additional 12-item subscale evaluation of nutritional QoL. Items are answered on a 5-point Likert scale from 0 (Not at all) to 4 (Very much). The global scores are calculated by summing the scores of the five individual QoL domains; higher scores indicate better quality of life.
Measured: Baseline (Day 1), Day 90
Evaluate effect on quality of life
Quality of Life will be assessed using the FAACT (functional assessment of anorexia/cachexia therapy) questionnaire. The FAACT questionnaire contains 40 items that measure four primary domains of global QoL along with specific anorexia/cachexia-related QoL issues. Physical well-being, social/family well-being, emotional well-being, and functional well-being comprise the four core measures of QoL, with an additional 12-item subscale evaluation of nutritional QoL. Items are answered on a 5-point Likert scale from 0 (Not at all) to 4 (Very much). The global scores are calculated by summing the scores of the five individual QoL domains; higher scores indicate better quality of life.
Measured: Baseline (Day 1), Day 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study startSep 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for DysgeusiaStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shirley Thomas, MD, MRCP (UK), MRCP (UK) Pall Med, PGDip Pall Med, Principal investigator, Case Comprehensive Cancer Center, Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07419581
- Sponsor's protocol ID
- CASE4Y25
- Status last verified
- Oct 2026
- First submitted
- 12 Feb 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36884274Murtaza 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.
PubMed 28337150Komurcu 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.
PubMed 12269782Speck 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.
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.
PubMed 36715776Lopez-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.
PubMed 38931260H. 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
Satiroff MKWaBA. Pilot Study of
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Explore the Effects of Freeze-Dried Miracle Fruit (MiraBurst) on Patients Receiving Cancer Treatment
- ClinicalTrials.gov ID
- NCT07419581
- Acronym / sponsor ID
- CASE4Y25
- Conditions
- Dysgeusia, Solid Tumor
- Keywords
- Freeze-Dried Miracle Fruit, MiraBurst
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cancer and the treatment of cancer can create many symptoms that impact people's lives. More than 90% of people with cancer have at least one symptom caused by their cancer or treatment. The most common symptoms are related to the gastrointestinal system. Change in sense of taste is the fourth most common symptom and may be described as "food not tasting the same as they use to, food tasting bland, everything tastes the same, or an unpleasant bitter or metallic taste." Change in taste can impact a person's quality of life, but there are not many options to treat this symptom.
The MiraBurst product used in this study comes from a berry fruit harvested in Ghana. The berries are freeze-dried into a powder and pressed into small, square pieces that each weigh 300 mg. The product is made from 100% pure miracle berry powder and has the same natural composition as the fresh berry. It contains no additives or preservatives. The berry is vegan, allergen-free, and gluten-free, and it has no known side effects. During processing, no substances are extracted from the berries except water. This product is not classified as a drug or a dietary supplement and does not contain any active or inactive ingredients. Because it is a pure berry powder, it does not go through a strict standardization process. Both the raw freeze-dried powder and the finished product (MiraBurst Mini Squares) are tested by third-party laboratories for microbial safety in both Ghana and the United States. The powder is also tested for heavy metals and goes through contaminant removal and metal detection during manufacturing. According to the manufacturer, the freeze-dried miracle berry powder is produced in a Good Manufacturing Practice (GMP)-compliant facility in Ghana. The manufacturing and packaging facilities for MiraBurst Mini Squares in the United States (Connecticut and New Jersey) are also GMP-compliant. There are no known interactions between this product and herbs or medications. The product is available over the counter and is commonly used several times a day, up to five times daily-before breakfast, snacks, lunch, and dinner.
Previous studies have shown that supplements made from the same miracle fruit can have promising effects for people with cancer. One pilot study in 2010 found that 30% of people who received miracle fruit for two weeks reported improvements in their taste perception. In another pilot study, all participants who received miracle fruit reported positive changes after two weeks. Participants reported that taste changes such as experiencing a sour or metallic taste improved and that foods tasted sweeter or more pleasant. Yet another study found these similar positive changes, while also finding that participants who received miracle berry also had a higher energy intake, increased fat-free mass, and improved quality of life compared to participants on placebo. Preclinical data on miracle berry extract indicate that it is relatively safe, with no significant toxicity reported. The active component in miracle berry, miraculin, is a glycoprotein that is rapidly and completely digested in the gastrointestinal (GI) tract. This makes systemic absorption and interaction with drug-metabolizing enzymes, such as CYP450 or MAO (monoamine oxidase), highly unlikely. Both in silico and in vitro analyses have demonstrated a low potential for allergenicity or cross-reactivity with other proteins.
This study seeks to confirm the promising and beneficial effects of miracle fruit, with a branded product (MiraBurst), which has appropriate manufacturing controls in place for quality consistency, on symptoms related to dysgeusia (alterations in taste perception).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MiraBurst | Experimental | Dietary Supplement: MiraBurstParticipants will consume one MiraBurst mini-square prior to each meal (up to four times per day) for a 90 day period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MiraBurstAlso: Freeze-Dried Miracle FruitParticipants will consume one 300 milligram (mg) MiraBurst mini-square prior to each meal (up to four times per day) for a 90 day period. | Dietary supplement | MiraBurst |
Primary outcome
Evaluate effect on taste perception
Time frame: Baseline (Day 1), Day 7
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.
Evaluate effect on taste perception
Time frame: Baseline (Day 1), Day 28
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.
Evaluate effect on taste perception
Time frame: Baseline (Day 1), Day 90
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.
Evaluate effect on taste perception
Time frame: Baseline (Day 1), Day 120
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.
8 secondary outcomes
Evaluate effect on weight
Time frame: Baseline (Day 1), Day 7
Evaluate effect on weight
Time frame: Baseline (Day 1), Day 28
Evaluate effect on weight
Time frame: Baseline (Day 1), Day 90
Evaluate effect on weight
Time frame: Baseline (Day 1), Day 120
Evaluate effect on quality of life
Time frame: Baseline (Day 1), Day 7
Evaluate effect on quality of life
Time frame: Baseline (Day 1), Day 28
Evaluate effect on quality of life
Time frame: Baseline (Day 1), Day 90
Evaluate effect on quality of life
Time frame: Baseline (Day 1), Day 120
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Background: PubMed 36884274Kang 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.
- Background: PubMed 28337150Murtaza 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.
- Background: PubMed 12269782Komurcu 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.
- 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.
- Background: PubMed 36715776Hiroyuki 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.
- Background: PubMed 38931260Lopez-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.
- BackgroundH. 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
- BackgroundSatiroff MKWaBA. Pilot Study of
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shirley Thomas, MD, MRCP (UK), MRCP (UK) Pall Med, PGDip Pall Med contact
Shirley Thomas, MD, MRCP (UK), MRCP (UK) Pall Med, PGDip Pall Med principal investigator
Case Comprehensive Cancer Center, Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MiraBurst in people with Dysgeusia and Solid Tumor, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shirley Thomas, MD, MRCP (UK), MRCP (UK) Pall Med, PGDip Pall Med (216-445-0132, thomass75@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate effect on taste perception (time frame: Baseline (Day 1), Day 7). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07419581, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.