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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

About this trial

This is an interventional treatment trial for Taste, Altered

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Data Monitoring Committee

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

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

Learn more about this trial

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

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