A Phase 2 Double-blind, Placebo-controlled Study of the Effects of Muscadine Grape Extract in Men With Prostate Cancer on Androgen Deprivation Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Changes in fatigue
研究概览
简要总结
It is estimated that one-third of the more than 7 million deaths from cancer worldwide are attributable to potentially modifiable risk factors, with 374,000 deaths preventable through diet modification alone. Diet supplementation for the prevention or treatment of cancer is attractive, as implementation is relatively easy, even in populations with reduced incomes and resources. Grape extracts or active components isolated from grapes have received attention as chemopreventive or therapeutic agents based upon their anti-proliferative, anti-inflammatory, and anti-oxidant properties. Evidence from preclinical trials also suggests that muscadine grape products may decrease systemic inflammation. This study builds upon promising preclinical and clinical evidence to determine if the addition muscadine grape extract (MGE) to androgen deprivation therapy (ADT) improves symptoms in men with prostate cancer.
详细描述
Primary Objective: To compare levels of fatigue in the MGE group compared to the placebo group at 6 months.
Secondary Objectives
- To compare levels of fatigue in the MGE group compared to the placebo group at 3, 9, and 12 months.
- To compare quality of life in men in the MGE group compared to the placebo group.
- To compare physical function, physical fitness, and body composition in men in the MGE group compared to the placebo group.
- To compare time to PSA progression (from study entry) in men in the MGE group compared to the placebo group.
- To compare progression-free survival (from study entry) in men in the MGE group compared to the placebo group.
OUTLINE: Participants are randomized into 1 of 2 groups.
GROUP I (Muscadine grape extract): Participants begin Androgen deprivation therapy prior to receiving muscadine grape extract and then receive muscadine grape extract orally (PO) twice daily (BID) for 12 months in the absence of disease progression or unacceptable toxicity.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
This is a double-blind study. Only the lead-site investigational pharmacy team and the statistician will unblinded. The blind will be maintained until the study is complete.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men age ≥18 years who are fluent in English.
- •Histologically confirmed prostate adenocarcinoma.
- •Prior surgical castration or active ongoing use of androgen deprivation therapy (ADT) with expectation by the treating physician that patient would remain on ADT for the upcoming 12 months. ADT in the setting of definitive radiation therapy permitted. Concurrent treatment with androgen pathway inhibitors (examples include enzalutamide, abiraterone, darolutamide, apalutamide) permitted..
- •Normal organ and marrow function function (labs within 30 days prior to study entry) as defined below:
- •White blood cell count greater than or equal to 3,500/mcL (or 3.5 (x103)) Platelet count greater than or equal to 75,000/mcL (or 75 (x103)) Hemoglobin greater than or equal to >9 g/dL Total bilirubin less than or equal to 2.5 X institutional upper limit of normal AST(SGOT)/ALT(SGPT) less than or equal to 2.5 X institutional upper limit of normal Creatinine less than or equal to 2.5 X institutional upper limit of normal
- •Able to ambulate (use of assist device is acceptable).
- •Able to cooperate with study-related activities.
- •The effects of MGE on the developing human fetus are unknown. Men must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
- •Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).
排除标准
- •Symptomatic metastatic disease requiring medical treatment (i.e., painful metastases to bone).
- •Prostate cancer related surgery or radiation within 60 days prior to study entry.
- •Documented rise in PSA (defined as rise of > 0.5 ng/mL) while on current prostate cancer therapy, determined by PSA values, at least one of which must be during the 6 months prior to study entry PSA values must be at least 7 days apart.
- •Planned cessation of ADT or planned use of cytotoxic chemotherapy (i.e., docetaxel) within 12 months after study entry.
- •Ongoing use of any other investigational cancer-directed agents.
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to MGE.
- •Inability to swallow oral medications.
- •Malabsorption due to bowel resection or gastrointestinal disease leading to uncontrolled diarrhea, or persistent nausea or vomiting requiring daily antiemetic therapy for symptom management within the past week.
- •Uncontrolled intercurrent illness, including but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
研究组 & 干预措施
MGE group
Patients will be randomized to muscadine grape extract (MGE). The patients will take 4 capsules by mouth BID (twice daily). Androgen deprivation therapy (ADT) is to be started within 60 days prior to initiation of MGE.
干预措施: MGE (Drug)
MGE group
Patients will be randomized to muscadine grape extract (MGE). The patients will take 4 capsules by mouth BID (twice daily). Androgen deprivation therapy (ADT) is to be started within 60 days prior to initiation of MGE.
干预措施: ADT (Other)
Placebo group
Patients will be randomized to placebo. The patients will take 4 capsules by mouth BID (twice daily). Androgen deprivation therapy (ADT) is to be started within 60 days prior to initiation of placebo.
干预措施: Placebo (Other)
Placebo group
Patients will be randomized to placebo. The patients will take 4 capsules by mouth BID (twice daily). Androgen deprivation therapy (ADT) is to be started within 60 days prior to initiation of placebo.
干预措施: ADT (Other)
结局指标
主要结局
Changes in fatigue
时间窗: Baseline and 6 months
The PROMIS Fatigue 7a Short-Form assesses the experience (3 items) and impact (4 items) of fatigue. Item responses are rated on a five-point scale ranging from "never" to "always" and are summed for a total score and transformed to a T-score metric. Higher scores indicate more fatigue. Recommendations for classifying fatigue based on the T scores are as follows: \<50 normal; 50-59 mild; 60-69 moderate; ≥70 severe.
次要结局
- Changes in self-reported physical function(Baseline and 6 months)
- Changes in physical performance(Baseline and 6 months)
- Changes in sub-maximal exercise(baseline and 6 month)
- Progression-free survival(up to 12 months)
- Changes in quality of life: PROMIS(Baseline and 6 months)
- Changes in quality of life: HFRDIS(Baseline and 6 months)
- Changes in sleep disturbance(Baseline and 6 months)
- Changes in cognitive abilities(Baseline and 6 months)
- Changes in body composition(Baseline and 6 months)
- Changes in prostate-specific antigen (PSA) progression(baseline, 6, and 12 months)