Dysgeusia, Solid Tumor
Conditions
Keywords
Freeze-Dried Miracle Fruit, MiraBurst
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.
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).
Interventions
DIETARY_SUPPLEMENTMiraBurst
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.
Sponsors
Case Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate effect on taste perception | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate effect on weight | Baseline (Day 1), Day 7 | Change in weight will be quantified as an absolute number change from baseline (in pounds (lbs)), as well as a percent change from baseline. |
| Evaluate effect on quality of life | Baseline (Day 1), Day 7 | 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. |
Countries
United States
Contacts
CONTACTShirley Thomas, MD, MRCP (UK), MRCP (UK) Pall Med, PGDip Pall Med
PRINCIPAL_INVESTIGATORShirley Thomas, MD, MRCP (UK), MRCP (UK) Pall Med, PGDip Pall Med
Case Comprehensive Cancer Center, Cleveland Clinic
Outcome results
None listed