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
About this trial
This is an interventional treatment trial for Taste, Altered
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.
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
NCT ID
NCT04629560
First Posted
November 10, 2020
Last Updated
November 10, 2020
Sponsor
Mt. Sinai Medical Center, Miami
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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