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

Primary Purpose

Taste, Altered, Dysgeusia

Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Miracle Fruit
Sponsored by
Mt. Sinai Medical Center, Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Taste, Altered

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Miracle Fruit Arm

    Control Arm (supportive measures only)

    Arm Description

    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.

    standard of care supportive measures

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Compare weight loss in treatment vs. control arms
    Weight loss will be determined by comparing baseline (pre-intervention) weight with on-study weight.

    Full Information

    First Posted
    November 10, 2020
    Last Updated
    November 10, 2020
    Sponsor
    Mt. Sinai Medical Center, Miami
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04629560
    Brief Title
    Miracle Fruit Powder for the Treatment of Taste Alterations Secondary to Chemotherapy
    Official Title
    Miracle Fruit Powder for the Treatment of Taste Alterations Secondary to Chemotherapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    August 18, 2008 (Actual)
    Primary Completion Date
    June 20, 2011 (Actual)
    Study Completion Date
    June 20, 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mt. Sinai Medical Center, Miami

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Taste, Altered, Dysgeusia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Crossover Assignment
    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)
    Allocation
    Randomized
    Enrollment
    48 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Miracle Fruit Arm
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control Arm (supportive measures only)
    Arm Type
    No Intervention
    Arm Description
    standard of care supportive measures
    Intervention Type
    Drug
    Intervention Name(s)
    Miracle Fruit
    Other Intervention Name(s)
    supportive care
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Compare the incidence of taste alteration in treatment vs. control arms
    Description
    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.
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Compare weight loss in treatment vs. control arms
    Description
    Weight loss will be determined by comparing baseline (pre-intervention) weight with on-study weight.
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mike Cusnir, MD
    Organizational Affiliation
    Mount Sinai Medical Center of Florida
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    8777177
    Citation
    Griffin AM, Butow PN, Coates AS, Childs AM, Ellis PM, Dunn SM, Tattersall MH. On the receiving end. V: Patient perceptions of the side effects of cancer chemotherapy in 1993. Ann Oncol. 1996 Feb;7(2):189-95. doi: 10.1093/oxfordjournals.annonc.a010548.
    Results Reference
    result
    PubMed Identifier
    17710445
    Citation
    Bernhardson BM, Tishelman C, Rutqvist LE. Self-reported taste and smell changes during cancer chemotherapy. Support Care Cancer. 2008 Mar;16(3):275-83. doi: 10.1007/s00520-007-0319-7. Epub 2007 Aug 21.
    Results Reference
    result
    PubMed Identifier
    17563467
    Citation
    Marin Caro MM, Laviano A, Pichard C. Impact of nutrition on quality of life during cancer. Curr Opin Clin Nutr Metab Care. 2007 Jul;10(4):480-7. doi: 10.1097/MCO.0b013e3281e2c983.
    Results Reference
    result
    PubMed Identifier
    10337648
    Citation
    Wickham RS, Rehwaldt M, Kefer C, Shott S, Abbas K, Glynn-Tucker E, Potter C, Blendowski C. Taste changes experienced by patients receiving chemotherapy. Oncol Nurs Forum. 1999 May;26(4):697-706.
    Results Reference
    result
    PubMed Identifier
    17394940
    Citation
    Halyard MY, Jatoi A, Sloan JA, Bearden JD 3rd, Vora SA, Atherton PJ, Perez EA, Soori G, Zalduendo AC, Zhu A, Stella PJ, Loprinzi CL. Does zinc sulfate prevent therapy-induced taste alterations in head and neck cancer patients? Results of phase III double-blind, placebo-controlled trial from the North Central Cancer Treatment Group (N01C4). Int J Radiat Oncol Biol Phys. 2007 Apr 1;67(5):1318-22. doi: 10.1016/j.ijrobp.2006.10.046.
    Results Reference
    result
    PubMed Identifier
    5673432
    Citation
    Kurihara K, Beidler LM. Taste-modifying protein from miracle fruit. Science. 1968 Sep 20;161(3847):1241-3. doi: 10.1126/science.161.3847.1241.
    Results Reference
    result
    PubMed Identifier
    5684879
    Citation
    Brouwer JN, van der Wel H, Francke A, Henning GJ. Mieraculin, the sweetness-inducing protein from miracle fruit. Nature. 1968 Oct 26;220(5165):373-4. doi: 10.1038/220373a0. No abstract available.
    Results Reference
    result
    PubMed Identifier
    17020807
    Citation
    Yamamoto C, Nagai H, Takahashi K, Nakagawa S, Yamaguchi M, Tonoike M, Yamamoto T. Cortical representation of taste-modifying action of miracle fruit in humans. Neuroimage. 2006 Dec;33(4):1145-51. doi: 10.1016/j.neuroimage.2006.08.009. Epub 2006 Oct 3.
    Results Reference
    result
    PubMed Identifier
    18005911
    Citation
    Eton DT, Temple LM, Koffler K. Pilot validation of a self-report outcome measure of complementary and alternative medicine. Explore (NY). 2007 Nov-Dec;3(6):592-9. doi: 10.1016/j.explore.2007.08.004.
    Results Reference
    result

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

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