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

Early Phase 1

Completed

• Conditions: Taste, Altered; Dysgeusia
• Interventions: Drug: Miracle Fruit

• Registration Number: NCT04629560
• Lead Sponsor: Mt. Sinai Medical Center, Miami

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

Study Timeline

• Study Start: 2008-08-18
• Primary Completion: 2011-06-20
• Study Completion: 2011-06-20
• Status Verified: 2020-11
• Study First Submitted: 2020-11-10
• Study First Submitted QC: 2020-11-10
• Last Update Submitted: 2020-11-10
• Study First Posted: 2020-11-16
• Last Update Posted: 2020-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Miracle Fruit Arm	Miracle Fruit	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.

Primary Outcome Measures

Name	Time	Method
Compare the incidence of taste alteration in treatment vs. control arms	12 months	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

Name	Time	Method
Compare weight loss in treatment vs. control arms	12 months	Weight loss will be determined by comparing baseline (pre-intervention) weight with on-study weight.