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

NCT04629560 | Completed Early Phase 1 FDA Drug

• 1 other identifier: MIRACLE FRUIT
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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

Conditions

Taste, Altered; Dysgeusia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Compare weight loss in treatment vs. control arms

  12 months

Study Arms (2)

Miracle Fruit Arm

EXPERIMENTAL

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

Control Arm (supportive measures only)

NO INTERVENTION

standard of care supportive measures

Interventions

Miracle Fruit DRUG

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

Also known as: supportive care

Miracle Fruit Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mt. Sinai Medical Center, Miami: lead

Related Publications (9)

• 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: 8777177 RESULT

• 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: 17710445 RESULT

• 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: 17563467 RESULT

• 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: 10337648 RESULT

• 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: 17394940 RESULT

• 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: 5673432 RESULT

• 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: 5684879 RESULT

• 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: 17020807 RESULT

• 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.

  PMID: 18005911 RESULT

MeSH Terms

Conditions

Dysgeusia

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Taste Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Mike Cusnir, MD

  Mount Sinai Medical Center of Florida

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director Cancer Center/Chief of Hematology Oncology

Model Details: 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.

Study Record Dates

• First Submitted: November 10, 2020
• First Posted: November 16, 2020
• Study Start: August 18, 2008
• Primary Completion: June 20, 2011
• Study Completion: June 20, 2011
• Last Updated: November 16, 2020

Record last verified: 2020-11