Miracle Fruit Powder for the Treatment of Taste Alterations Secondary to Chemotherapy
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 主要终点
- Compare the incidence of taste alteration in treatment vs. control arms
研究概览
简要总结
Purpose and Objective: Compare the incidence of taste alteration in treatment vs. control arms and Compare weight loss in treatment vs. control arms
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •• 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.
研究组 & 干预措施
Miracle Fruit Arm
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.
干预措施: Miracle Fruit (Drug)
结局指标
主要结局
Compare the incidence of taste alteration in treatment vs. control arms
时间窗: 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.
次要结局
- Compare weight loss in treatment vs. control arms(12 months)
研究者
Mike Cusnir
Medical Director Cancer Center/Chief of Hematology Oncology
Mt. Sinai Medical Center, Miami