Addressing Taste Dysfunction With Miraculin in Head and Neck Cancer Patients Receiving Radiation Therapy: A Double-blinded, Placebo-controlled, Randomized Phase III Trial
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in Taste Assessment scores over time
研究概览
简要总结
Patients diagnosed with head and neck cancer who receive radiation therapy with and without chemotherapy develop altered sense of taste due to treatment effect, which typically arises in the second week of radiation therapy and progresses throughout the course of treatment. While some symptoms such as pain, mucositis, and xerostomia can be managed with pain medications and saliva replacements, taste alteration has an earlier onset and is a more difficult symptom to readily address and intervene upon. There are no effective established interventions for taste, although this is a major issue in the patient experience. The investigator will be examining they hypothesis that a miracle fruit cube would yield the greatest benefit to improve taste dysfunction in the beginning half of radiation treatment when taste function is decreased but not absent.
详细描述
This is a Phase III, single-center, double-blinded, placebo-controlled, randomized controlled trial.
PRIMARY OBJECTIVE:
I. To determine if the use of miracle fruit during radiation therapy for head and neck cancer patients can reduce the effect of subjective taste alteration influence on dietary intake.
SECONDARY OBJECTIVE:
I. To characterize changes in weight, quality of nutritional intake, patient-reported taste dysfunction and quality of life, frequency of significant medical events or treatment complications, and association between oral cavity radiation dose and dysgeusia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Packaging and labeling of test and control treatments will be identical and performed by Miracle Fruit Farm to maintain blinding conditions.
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
- •Participants must have documentation of histologically or cytologically confirmed head and neck cancer diagnosis including primary tumors of the following sites: oropharynx, nasopharynx, oral cavity, nasal cavity, paranasal sinus, salivary gland, unknown primary origin in the head and neck, or cutaneous squamous cell carcinoma having had a surgery including neck dissection.
- •Treatment plan includes curative-intent (including post-operative) radiation therapy with or without concurrent chemotherapy
- •Age >=18 years at screening visit.
- •Eastern Cooperative Oncology Group (ECOG) performance status <= 2 (Karnofsky >= 60%)
- •Ability to understand a written informed consent document, and the willingness to sign it
排除标准
- •Patient-reported pre-existing dysgeusia prior to beginning radiation therapy.
- •Receiving nutrition through tube feeds or intravenously prior to beginning radiation therapy.
- •Inability to complete patient-reported outcomes (PROs) and quality of life questionnaires in English.
- •Known allergy to berries.
研究组 & 干预措施
Miracle Fruit Placebo
Participants will receive 1 placebo cube by mouth three times a day before meals
干预措施: Miracle Fruit Placebo Cube (Dietary Supplement)
Miracle Fruit
Participants will receive 1 Miracle Fruit Farm miracle fruit cube by mouth three times a day before meals
干预措施: Miraculin (Drug)
结局指标
主要结局
Change in Taste Assessment scores over time
时间窗: 21 days
The Taste Assessment is a two-item questionnaire used to determine the overall experiences of the participant taste sensation in the past 7 days; with one item asking about taste alteration and another asking about the interference of taste alteration with dietary intake. Scores for each item are obtained by responses to a Likert scale ranging from 1= "not at all" to 5="a lot", with greater scores indicating a greater taste alteration or interference.
次要结局
- Change in the European Organization for Research and Treatment of Head and Neck (EORTC QLQ-H&N35) scores over time(Up to 6 months)
- Change in body weight over time(Up to 6 months)
- Change in Diet Diversity Scores over time(Up to 6 months)
- Change in Chemotherapy-induced taste alteration scale (CiTAS) scores over time(Up to 6 months)
- Change in the Bernhardson Questionnaire scores over time(Up to 6 months)
- Change in EuroQol five-dimensional Questionnaire (EQ-5D) scores over time(Up to 6 months)
- Proportion of participants requiring percutaneous gastric tubes (PEG) over time(Up to 6 months)
- Proportion of participants requiring hospital admission over time(Up to 6 months)
- Number of participants who returned unused product(At 60 days)
- Number of participants who returned weekly recall items(At 60 days)
- Percentage of participants compliant with study treatment(At 60 days)