Miracle Fruit Powder for the Treatment of Taste Alterations Secondary to Chemotherapy

Study Overview
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Brief Summary
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Purpose and Objective: Compare the incidence of taste alteration in treatment vs. control arms and Compare weight loss in treatment vs. control arms

Detailed Description
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After patients is explained all potential risks and study guidelines all patients will be given an ICF to sign if they wish to participate. Once the ICF has been signed by patient approximately between 3-5 days will undergo a screening to determine protocol eligibility. If patients qualifies (eligible) for study patients will be randomly assigned either to the miracle fruit intervention or to supportive measures at first and later participants will cross over to the other intervention

Official Title
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Miracle Fruit Powder for the Treatment of Taste Alterations Secondary to Chemotherapy

Conditions
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Taste, Altered, Dysgeusia

Intervention / Treatment
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* Drug: Miracle Fruit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The inclusion criteria are the following: Patients over 18 years old with a life expectancy of 3 months or more. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 At enrollment, patients must be able to take oral medications and food reliably without any risk factors for aspiration. Patients that have received at least 1 cycle of chemotherapy and have at least 1 more cycle planned. Patients receiving the following drug-containing chemotherapy regimens: cyclophosphamide, carboplatin, cisplatinum, gemcitibine, methotrexate, doxorubicin, 5-fluorouracil, paclitaxel, docetaxel, vinorelbine, oxaliplatin, irinotecan and etoposide. Patients receiving radiotherapy at the time of chemotherapy are allowed, with the exception of patients receiving radiotherapy for head and neck tumors Patients with the ability to understand and the willingness to sign a written informed consent document written in English and answer all appropriate questionnaires in English or Spanish. (see Appendix 3) Patients with brain metastases are eligible if neurologically stable after appropriate treatment (surgery and/or radiation). Exclusion Criteria: • Patient that have mechanical obstruction of the alimentary tract. Patients who have developed decreased/altered taste sensation for any reason besides chemotherapy Patients with malabsorption or intractable vomiting. Patients who have extensive dental caries Patients who have poor oral hygiene Patients receiving radiotherapy for head and neck tumors. Previous surgery that included ablation or removal of the olfactory component of the taste. Untreatable oral thrush. Women that are pregnant, nursing or of childbearing potential and unwilling to use contraception, as the effects of the miracle fruit on the developing human fetus are unknown. Patients with an ANC < 500/uL . Patients with poorly controlled diabetes mellitus (DM) as determined by their primary physicians will be excluded from the study. All DM patients will be required to check their blood sugar on their usual home glucose meters at least once a day, prior to the ingestion of the miracle fruit. If the patient does not a glucose meter, we will provide the patient with one. Any case of hypoglycemia (blood sugar below 60) should be reported immediately to the treatment physician and the patient should stop the miracle fruit treatment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Patients will be randomly assigned either to the miracle fruit intervention or to supportive measures at first and later participants will cross over to the other intervention.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Miracle Fruit Arm<br>Patient will be randomly assigned, by a computer generated randomization, to receive one miracle fruit tablet of 100 mg 10-15 minutes before lunch and dinner versus supportive measures. | Drug: Miracle Fruit<br>* one miracle fruit tablet of 100 mg 10-15 minutes before lunch and dinner versus supportive measures. Patients assigned to receive the miracle fruit will receive written instructions regarding the use of the fruit. Patients should put the fruit tablet or powder in the mouth and gently chew/suck to dissolve and cover the tongue with the powder<br>* Other names: supportive care;|
| No Intervention: Control Arm (supportive measures only)<br>standard of care supportive measures | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the incidence of taste alteration in treatment vs. control arms | Taste alteration will be assessed using questions from the Wickham questionnaire of taste alterations. Patient responses to these questions will be transformed to a 0 to 100 scale. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare weight loss in treatment vs. control arms | Weight loss will be determined by comparing baseline (pre-intervention) weight with on-study weight. | 12 months |