Effects of Muscadine Grape Extract in Men With Prostate Cancer on Androgen Deprivation Therapy
Ключови думи
Резюме
Описание
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. The muscadine grape contains a high concentration of anthocyanin 3,5-diglucosides, ellagic acid, ellagic acid precursors, gallic acid, flavan-3-ols and flavonols. Several preclinical studies with muscadine grape products have revealed anti-tumor activity, including inhibition of tumor cell growth and induction of apoptosis. By reducing levels of circulating inflammatory markers such as CRP and IL-6, muscadine grape products may improve cancer outcomes by decreasing symptom burden, particularly fatigue. Despite reports indicating potential anti-tumor activity, there are limited clinical studies on the efficacy of muscadine grape products in the prevention or treatment of cancer or cancer-related side effects, representing an opportunity for novel investigation. The primary goal will be to determine whether treatment with MGE can improve measures of fatigue in men with biochemically recurrent prostate cancer on androgen deprivation therapy (ADT).
Patients will be followed for up to 12 months from study initiation for disease progression or death.
Дати
| Последна проверка: | 12/31/2019 |
| Първо изпратено: | 04/04/2018 |
| Очаквано записване подадено: | 04/04/2018 |
| Първо публикувано: | 04/11/2018 |
| Изпратена последна актуализация: | 01/08/2020 |
| Последна актуализация публикувана: | 01/13/2020 |
| Действителна начална дата на проучването: | 01/28/2019 |
| Приблизителна дата на първично завършване: | 11/30/2020 |
| Очаквана дата на завършване на проучването: | 05/31/2021 |
Състояние или заболяване
Интервенция / лечение
Drug: MGE group
Other: Placebo group
Other: ADT
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| Experimental: 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. | Drug: MGE group The patients will take 4 capsules by mouth BID (twice daily). |
| Placebo Comparator: 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. | Other: Placebo group The patients will take 4 capsules by mouth BID (twice daily). |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 18 Years Да се 18 Years |
| Полове, допустими за проучване | Male |
| Приема здрави доброволци | Да |
| Критерии | Inclusion Criteria: - Men age ≥18 years who are fluent in English. - Histologically confirmed prostate adenocarcinoma. - Definitive therapy of primary prostate tumor completed. Definitive therapy can be prostatectomy, primary radiation therapy, brachytherapy, or cryotherapy. Salvage radiation after prostatectomy is allowed, if completed >60 days prior to study entry. - Prior surgical castration or active use of androgen deprivation therapy (ADT) alone, with expectation by the treating physician that patient would remain on ADT alone for upcoming 12 months, without escalating therapy. Prior ADT in the setting of definitive radiation therapy permitted. - Normal organ and marrow function function (labs within 30 days prior to study entry) as defined below: White blood cell count >3,500/mcL (or 3.5 (x103)) Platelet count >75,000/mcL (or 75 (x103)) Hemoglobin >9 g/dL Total bilirubin <2.5 X institutional upper limit of normal AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal Creatinine <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). Exclusion Criteria: - Symptomatic metastatic disease. - Any cancer treatment other than ADT within 30 days prior to study entry. - Documented rise in PSA (defined as rise of > 0.5 ng/mL) while on continuous ADT during the 6 months prior to study entry PSA values must be at least 7 days apart. - Planned cessation of ADT or planned escalation of prostate cancer therapy 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. |
Резултат
Първични изходни мерки
1. Changes in fatigue [Baseline and 6 months]
Вторични изходни мерки
1. Changes in quality of life: PROMIS [Baseline and 6 months]
2. Changes in quality of life: HFRDIS [Baseline and 6 months]
3. Changes in sleep disturbance [Baseline and 6 months]
4. Changes in cognitive abilities [Baseline and 6 months]
5. Changes in self-reported physical function [Baseline and 6 months]
6. Changes in physical performance [Baseline and 6 months]
7. Changes in sub-maximal exercise [baseline and 6 month]
8. Changes in body composition [Baseline and 6 months]
9. Changes in prostate-specific antigen (PSA) progression [baseline, 6, and 12 months]
10. Progression-free survival [up to 12 months]
