NCT01819948已完成不适用
Pilot Clinical Trial to Assess Changes in Biomarkers of Cancer Related to Inflammation in Women With Stage 0-IIIA Breast Cancer and Without Evidence of Disease Who Were Given the PhytoMed™ Complement.
Phytogen Medical Foods S.L.5 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2012年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 5
- 主要终点
- Reduction in the levels of CRP
研究概览
简要总结
The purpose of this study is to determine whether the administration of the PhytoMed™ complement reduces CRP in women with histologically confirmed AJCC Stage 0-IIIA breast cancer which has been completely surgically resected and without evidence of disease as determined by their physician
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with histologically confirmed AJCC Stage 0-IIIA breast cancer which has been completely surgically resected.
- •No evidence of disease as determined by their physician.
- •ER+ and/or PR+ tumour.
- •Receiving an aromatase inhibitor (letrozole, anastrazole, exemestane) or tamoxifen at a stable dose for at least 3 months at trial entry.
- •Post-menopausal women, defined as: (1) above 50 years of age who have not menstruated during the preceding 12 months or who have follicle-stimulating hormone levels (FSH) > 40 IU/L, (2) those under 50 years of age who have FSH hormone levels >40 IU/L, or (3) those who have undergone a bilateral oophorectomy.
- •CRP ≥3.9 mg/L measured as the mean of two consecutive weekly tests.
- •Aged 18 years or older
- •ECOG performance status 0-1
- •Between 2 and 5 years from their initial surgery for breast cancer.
- •Life expectancy of at least 6 months
- •At least 6 months since last chemotherapy
- •Laboratory tests performed within 14 days of trial starting:
- •Granulocytes ≥ 1,500/µL;
- •Platelets ≥ 100,000/µL;
- •Haemoglobin ≥ 12.0 g/dL;
- •Total bilirubin equal to or below upper limit of normal (ULN);
- •AST and ALT equal to or below ULN;
- •Alkaline phosphatase equal to or below ULN;
- •Serum creatinine equal to or below ULN;
- •Able to provide informed consent to receive the trial treatment, to provide biological specimens, self-administer oral medica-tion unsupervised for a prolonged period of time, and to complete a medication diary.
排除标准
- •Pregnancy or breastfeeding
- •Who have had a malignancy (other than breast cancer) which required radiotherapy or systemic treatment within the past 5 years.
- •Known cardiac disease (arrhythmias, myocardial infarction, bundle branch block, ischemic heart disease, uncontrolled hypertension)
- •Known autoimmune disease or inflammatory disorder
- •Any condition requiring the use of systemic corticosteroids or any other immunosuppressive agents (e.g. cyclosporin, tacrolimus, azathioprine).
- •Women with known immunodeficiency (such as HIV).
- •Patients with infection by septicaemia, infection, acute hepatitis, or other uncontrolled severe medical condition
- •Routine use of aspirin >81 mg/d or NSAIDs (> 400 mg po 4 times/day of ibuprofen or naproxen > 500 mg/d) or any use of celecoxib or similar COX-2 inhibitors;
- •Subjects are asked not to take dietary supplements, olives or olive oil for 1 month prior to trial enrolment and during the trial.
- •Who are taking bisphosphonates
研究组 & 干预措施
single-arm
Experimental
Two capsules in the morning, one at night, every day for a month, taken with a glass of water.
干预措施: PhytoMed™ (Dietary Supplement)
结局指标
主要结局
Reduction in the levels of CRP
时间窗: Baseline and 33 +/- 2 days
Reduction in serum levels of CRP from selection period to end-of-treatment
次要结局
- Increase in the levels of IL-10(Baseline and 33 +/- 2 days)
- Reduction in IL-6(Baseline and 33 +/- 2 days)
- Reduction SAA (serum amyloid A)(Baseline and 33 +/- 2 days)
- Reduction TNF-alpha(Baseline and 33 +/- 2 days)
- Pain intensity score measured with the BPI scale(Baseline and 33 +/- 2 days)
- Reduction IFNgamma(Baseline and 33 +/- 2 days)
- Increase in the levels of TGFbeta (transforming growth factor beta)(Baseline and 33 +/- 2 days)
- Safety and tolerability (Gastrointestinal symptoms)(Baseline and 33 +/- 2 days)
- Effect on lipid profile(Baseline and 33 +/- 2 days)
- Reduction in IGF (insulin growth factor)(Baseline and 33 +/- 2 days)
研究者
研究点 (5)
Loading locations...
相似试验
Unknown
不适用
Study for the Validation of a New Biomarker to Determine Predisposition to Infections in Patients With Acute Myocardial Infarction.Infections in Acute Myocardial Infarction PatientsNCT05412732Instituto de Investigación Hospital Universitario La Paz300
已完成
不适用
A Protocol of the Canadian Prospective Study for Hepatocellular Carcinoma Surveillance Using BiomarkersChronic Liver DiseasesCirrhosisNCT02272504Wako Life Sciences2,500
已完成
1 期
A Study of Olaratumab (LY3012207) in Participants With Soft Tissue SarcomaSoft Tissue SarcomaNCT02783599Eli Lilly and Company51
招募中
2 期
Ambroxol in New and Early DLB, A Phase IIa Multicentre Randomized Controlled Double Blind Clinical TrialDementia With Lewy BodiesNCT04588285Helse Fonna180
已完成
1 期
A Study of Pembrolizumab on the Tumoral Immunoprofile of Gynecologic CancersGynecologic NeoplasmsUterine Endometrial CancerFallopian Tube CancerPeritoneal CancerEpithelial Ovarian CancerNCT02728830AA Secord39