A Study of Freeze-Dried Miracle Fruit (MiraBurst) on Participants Receiving Cancer Treatment
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCase Comprehensive Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years and above
Solid tumor cancer diagnosis
Participants on active cancer treatment
Eastern Cooperative Oncology Group (ECOG) score of 0 to 2
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
MiraBurst
Dietary supplementParticipants will consume one 300 milligram (mg) MiraBurst mini-square prior to each meal (up to four times per day) for a 90 day period.
Treatment groups
45 Participants
are divided into 1 treatment groupGroup A: MiraBurstExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (Day 1), Day 72
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.
Time frame
Baseline (Day 1), Day 283
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.
Time frame
Baseline (Day 1), Day 904
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.
Time frame
Baseline (Day 1), Day 120Secondary outcomes
1
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.
Time frame
Baseline (Day 1), Day 72
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.
Time frame
Baseline (Day 1), Day 283
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.
Time frame
Baseline (Day 1), Day 904
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.
Time frame
Baseline (Day 1), Day 120Sponsors and contacts
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Source ClinicalTrials.gov
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