Clinical trial NCT04629560: 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
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Taste, Altered
Dysgeusia
Lead sponsor: Mt. Sinai Medical Center, Miami
Sponsor class: OTHER
First posted: 2020-11-16
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Compare the incidence of taste alteration in treatment vs. control arms
timeFrame: 12 months
Secondary outcomes:
measure: Compare weight loss in treatment vs. control arms
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Mount Sinai Medical Center of Florida
name: Mike Cusnir, MD
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.