Preoperative Use of Tocotrienol Associated With Personalized Nutritional and Psychoeducational Support in Women With Primary Breast Cancer.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Changes in blood oxidant capacity
研究概览
简要总结
Tocotrienols have shown strong in vitro and in vivo anti-oxidant and anticancer activity, promoting apoptosis and regulating oncogenic targets in breast cancer. However their clinical use is still experimental especially in preoperative setting, where there are still no data of antioxidant and antiinflammatory beneficial roles. This study is a prospective observational clinical study enrolling 50 patients with primary breast cancer (T1-2, N0-1, M0) who received 4-weeks oral treatment of delta-T3 before surgery (200 mg/twice daily) with personalized nutritional and psychoeducational support. This study evaluates the effects of treatment on oxidant (tock fast-Li Starfish) and antioxidant capacity (TAC Track, Li Starfish), anti-inflammatory activity (complete profiling of adaptive and innate cell immunity, immunologic serum markers (miRNA)), immunological response on tumor (gene expression profiling on preoperative tissue tumor biopsy and on surgical specimen), TNF-alpha, IL-6 and VEGF and proliferation/apoptosis, anti-inflammatory and anti-oxidant activity of breast cancer cell lines.
This study evaluates the effects of treatment on oxidant (tock fast-Li Starfish) and antioxidant capacity (TAC Track, Li Starfish), on anti-inflammatory activity (complete profiling of adaptive and innate cell immunity, immunologic serum markers (miRNA)), on immunological response on tumor (gene expression profiling on preoperative tissue tumor biopsy and on surgical specimen), on TNF-alpha, IL-6 and VEGF, on proliferation/apoptosis, anti-inflammatory and anti-oxidant activity of breast cancer cell lines.
详细描述
An open-label, single center, phase 2 prospective observational clinical study
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically confirmed operable primary breast cancer (T1-T2 N0-1 M0)
- •absence of distant metastasis
- •signed informed consent.
排除标准
- •Previous malignancies other than in situ cervical carcinoma or nonmelanoma skin cancer
- •Breast cancer recurrence
- •Metastatic breast cancer
- •Non-epithelial breast cancer at histological examination
- •In situ lobular breast cancer
- •Participation in other randomized clinical trials that could interfere with current study
- •Living distant from center and unable to attend for check-ups and meetings
研究组 & 干预措施
Tocotrienol
Subjects receiveTocotrienol 200 mg/twice daily before surgery
干预措施: Tocotrienol (Drug)
结局指标
主要结局
Changes in blood oxidant capacity
时间窗: 4 weeks
Oxidant capacity (through tock fast-Li Starfish) (µmol/L) was measured in patients' serum samples.
Changes in blood antioxidant capacity
时间窗: 4 weeks
Antioxidant capacity (through TAC Track, Li Starfish) (µmol/L) was measured in patients' serum samples.
Changes in immune response associated gene levels in preoperative tissue tumor biopsies and in surgical specimens, obtained before and after four weeks of tocotrienol treatment, respectively, as determined by gene expression profiling analysis
时间窗: 4 weeks
Immune response associated gene levels were determined by gene expression profiling analysis in preoperative tissue tumor biopsies and in surgical specimens, obtained before and after four weeks of tocotrienol treatment
Changes in serum inflammatory cytokines and growth factor
时间窗: 4 weeks
Blood inflammatory cytokines and growth factor (through TNF-alpha (pg/ml), IL-6 (pg/ml) and VEGF (pg/ml) quantifications) were measured in patients' serum samples
Absolute and relative changes in peripheral blood mononuclear cells obtained before and after four weeks of tocotrienol treatment, as detected by 13-colors citofluorimetry analysis
时间窗: 4 weeks
Peripheral blood mononuclear cells were measured by 13-color cytofluorimetry analysis in patients' serum samples.
Changes of immune-related miRNA levels in patients' serum samples obtained before and after four weeks of tocotrienol treatment, as determined by quantitative real-time PCR analysis
时间窗: 4 weeks
Immune-related miRNA levels were determined by quantitative real-time PCR analysis in patients' serum samples obtained before and after four weeks of tocotrienol treatment
次要结局
- Treatment-induced changes in proliferation/apoptosis, anti-inflammatory and anti-oxidant activity of breast cancer cell lines(12,24 and 72 hours)
- Changes in expression of tumor proliferation, hormone receptors and HER2(4 weeks)