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Purpose and Objective: Compare the incidence of taste alteration in treatment vs. control arms and Compare weight loss in treatment vs. control arms
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control Arm (supportive measures only) | No Intervention | standard of care supportive measures |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Compare weight loss in treatment vs. control arms | Weight loss will be determined by comparing baseline (pre-intervention) weight with on-study weight. | 12 months |
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Inclusion Criteria:
The inclusion criteria are the following:
Exclusion Criteria:
• Patient that have mechanical obstruction of the alimentary tract.
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| Name | Affiliation | Role |
|---|---|---|
| Mike Cusnir, MD | Mount Sinai Medical Center of Florida | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8777177 | Result | 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. | |
| 17710445 | 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. |
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| ID | Term |
|---|---|
| D004408 | Dysgeusia |
| ID | Term |
|---|---|
| D013651 | Taste Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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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.
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|
| 17563467 | 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. |
| 10337648 | 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. |
| 17394940 | 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. |
| 5673432 | 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. |
| 5684879 | 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. |
| 17020807 | 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. |
| 18005911 | 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. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |