Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-26 @ 12:47 AM
Study NCT ID:
NCT04629560
Status:
COMPLETED
Last Update Posted:
2020-11-16
First Post:
2020-11-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Miracle Fruit Powder for the Treatment of Taste Alterations Secondary to Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004408', 'term': 'Dysgeusia'}], 'ancestors': [{'id': 'D013651', 'term': 'Taste Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010166', 'term': 'Palliative Care'}], 'ancestors': [{'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2011-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-10', 'studyFirstSubmitDate': '2020-11-10', 'studyFirstSubmitQcDate': '2020-11-10', 'lastUpdatePostDateStruct': {'date': '2020-11-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare the incidence of taste alteration in treatment vs. control arms', 'timeFrame': '12 months', '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.'}], 'secondaryOutcomes': [{'measure': 'Compare weight loss in treatment vs. control arms', 'timeFrame': '12 months', 'description': 'Weight loss will be determined by comparing baseline (pre-intervention) weight with on-study weight.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Taste, Altered', 'Dysgeusia']}, 'referencesModule': {'references': [{'pmid': '8777177', 'type': 'RESULT', '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.'}, {'pmid': '17710445', 'type': 'RESULT', '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.'}, {'pmid': '17563467', 'type': 'RESULT', '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.'}, {'pmid': '10337648', 'type': 'RESULT', '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.'}, {'pmid': '17394940', 'type': 'RESULT', '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.'}, {'pmid': '5673432', 'type': 'RESULT', '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.'}, {'pmid': '5684879', 'type': 'RESULT', '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.'}, {'pmid': '17020807', 'type': 'RESULT', '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.'}, {'pmid': '18005911', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': 'Purpose and Objective: Compare the incidence of taste alteration in treatment vs. control arms and Compare weight loss in treatment vs. control arms', 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The inclusion criteria are the following:\n\n * Patients over 18 years old with a life expectancy of 3 months or more.\n * Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2\n * At enrollment, patients must be able to take oral medications and food reliably without any risk factors for aspiration.\n * Patients that have received at least 1 cycle of chemotherapy and have at least 1 more cycle planned.\n * Patients receiving the following drug-containing chemotherapy regimens: cyclophosphamide, carboplatin, cisplatinum, gemcitibine, methotrexate, doxorubicin, 5-fluorouracil, paclitaxel, docetaxel, vinorelbine, oxaliplatin, irinotecan and etoposide.\n * Patients receiving radiotherapy at the time of chemotherapy are allowed, with the exception of patients receiving radiotherapy for head and neck tumors\n * 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)\n * Patients with brain metastases are eligible if neurologically stable after appropriate treatment (surgery and/or radiation).\n\nExclusion Criteria:\n\n* • Patient that have mechanical obstruction of the alimentary tract.\n\n * Patients who have developed decreased/altered taste sensation for any reason besides chemotherapy\n * Patients with malabsorption or intractable vomiting.\n * Patients who have extensive dental caries\n * Patients who have poor oral hygiene\n * Patients receiving radiotherapy for head and neck tumors.\n * Previous surgery that included ablation or removal of the olfactory component of the taste.\n * Untreatable oral thrush.\n * 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.\n * Patients with an ANC \\< 500/uL .\n * 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.'}, 'identificationModule': {'nctId': 'NCT04629560', 'briefTitle': 'Miracle Fruit Powder for the Treatment of Taste Alterations Secondary to Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Mt. Sinai Medical Center, Miami'}, 'officialTitle': 'Miracle Fruit Powder for the Treatment of Taste Alterations Secondary to Chemotherapy', 'orgStudyIdInfo': {'id': 'MIRACLE FRUIT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Miracle Fruit 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.', 'interventionNames': ['Drug: Miracle Fruit']}, {'type': 'NO_INTERVENTION', 'label': 'Control Arm (supportive measures only)', 'description': 'standard of care supportive measures'}], 'interventions': [{'name': 'Miracle Fruit', 'type': 'DRUG', 'otherNames': ['supportive care'], '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', 'armGroupLabels': ['Miracle Fruit Arm']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mike Cusnir, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Mount Sinai Medical Center of Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mt. Sinai Medical Center, Miami', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Director Cancer Center/Chief of Hematology Oncology', 'investigatorFullName': 'Mike Cusnir', 'investigatorAffiliation': 'Mt. Sinai Medical Center, Miami'}}}}