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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MiraBurst | Experimental | Participants will consume one MiraBurst mini-square prior to each meal (up to four times per day) for a 90 day period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Day 1), Day 7 |
| Evaluate effect on weight |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shirley Thomas, MD, MRCP (UK), MRCP (UK) Pall Med, PGDip Pall Med | Contact | 216-445-0132 | thomass75@ccf.org |
| Name | Affiliation | Role |
|---|---|---|
| Shirley Thomas, MD, MRCP (UK), MRCP (UK) Pall Med, PGDip Pall Med | Case Comprehensive Cancer Center, Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36884274 | Background | 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. | |
| 28337150 |
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| ID | Term |
|---|---|
| D004408 | Dysgeusia |
| ID | Term |
|---|---|
| D013651 | Taste Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| 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 |
Change in weight will be quantified as an absolute number change from baseline (in pounds (lbs)), as well as a percent change from baseline.
| 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. | 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. | 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. | 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. | 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. | 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. | Baseline (Day 1), Day 120 |
| 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. |
| 12269782 | 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. |
| 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. |
| 36715776 | 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. |
| 38931260 | 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. |
| 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 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |