Effect of Dietary Iodine Supplementation on the Proliferation of Breast Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Tumor response [change in size]
研究概览
简要总结
The trial investigates the effect of oral supplement of molecular iodine (I2) alone and in combination with 4 to 6 cycles of FEC/TE (5-fluorouracil, epirubicin, cyclophosphamide/taxotere, epirubicin) treatment in woman diagnosticated with early (stage II) and advance (stage III) breast cancer, respectively. The study analyzes the clinical response [tumor size, thyroid status, side effects (Common Toxicity Criteria V4.0)] and molecular mechanisms in the tumor samples (transcriptomic, proteins and immune responses).
详细描述
The leading causes of failure of breast cancer treatment are the rapid development of metastases and tumor resistance to antineoplastic drugs. Anthracyclines (doxorubicin (DOX), epirubicin, etc.) are the golden standard in neoadjuvant therapy and are commonly used in the FEC/TE (5-fluorouracil, epirubicin, cyclophosphamide/taxotere, epirubicin) combination therapy during advanced breast cancer. However, even when treated with this potent chemotherapeutic combination, 30% of patients develop chemoresistance and cardiomyopathic side effects. Previous studies support that the oral supplement of molecular iodine (I2) exerts synergistic antineoplastic and cardioprotective impact when used in combination with the DOX in rodent and canine mammary cancer model. The present study performed two randomized clinical groups including women with early (stage II) and advanced (stage III) breast cancer. In the Early group, women were treated with I2 (5 mg/day) or placebo (colored water) for 7 to 35 days. In the Advanced group, patients received treatment (I2 or placebo) along with 4 to 6 cycles of FEC/TE treatment. The study analyzes the clinical response [tumor size, thyroid status, side effects (Common Toxicity Criteria V4.0)] and molecular mechanisms in the tumor samples (transcriptomic, proteins and immune responses).
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
double blind
入排标准
- 年龄范围
- 18 Years 至 81 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed, stage II or III breast cancer
- •Scheduled to surgical of the primary tumor (stage II)
- •Will receive neoadjuvant FEC/TE chemotherapy (stage III).
- •age > 18 and < 81 years
- •Non-pregnant
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
排除标准
- •Known sensitivity to iodine or FEC/TE
- •Concurrent severe and/or uncontrolled disease
- •Myocardial infarction within the last six months before the study
- •Unstable or uncontrolled hypertension
- •Thyroid dysfunction
研究组 & 干预措施
Early Cancer placebo
The daily supplement of a vegetable colored water solution (drops) for 7 to 35 days in early breast cancer diagnosticated woman.
Placebo: vegetable colored water solution (drops). Evaluate the activity of placebo on tumor size, and molecular tumor response, as well as side effects attenuation
干预措施: Placebo (Drug)
Early Cancer Iodine
The daily supplement of an iodine solution (drops, 5 mg/day) for 7 to 35 days in early breast cancer diagnosticated woman
干预措施: iodine (Drug)
Advanced Cancer FEC/TE placebo
The daily supplement of an vegetable colored water solution (drops) within 4 to 6 cycles of chemotherapy with FEC/TE in advanced breast cancer diagnosticated woman.
Placebo: vegetable colored water solution (drops). Evaluate the adjuvancy of placebo in FEC/TE treatment on tumor size and molecular tumor response, as well as side effects attenuation.
干预措施: FEC/TE Placebo (Drug)
Advanced Cancer FEC/TE + Iodine
The daily supplement of an iodine solution (drops, 5 mg/day) within 4 to 6 cycles of chemotherapy with FEC/TE in advanced breast cancer diagnosticated woman Drug: Iodine solution (5 mg/day). Evaluate the adjuvancy of I2 on FEC/TE treatment on tumor size and molecular tumor response, as well as side effects attenuation.
Other Name: evaluating the adjuvancy of iodine supplement in FEC/TE treatment
干预措施: FEC/TE iodine (Drug)
结局指标
主要结局
Tumor response [change in size]
时间窗: 20 minutes
The size of the tumor is calculated by measuring the largest diameter of the tumor in the axial plane. The first measurement is obtained in the mammography taken before the start of the protocol and the second measurement is made on the tissue after surgery. The change percentage is obtained by dividing the final size between the initial size by 100.
Incidence of treatment-emergent adverse events [Safety and Tolerability]).
时间窗: 40 minutes
Presence or not of: Edema, hand-foot syndrome, anorexia, vomiting, diarrhea, nausea, asthenia (patient interview and clinical auscultation)
Differential Blood Count
时间窗: 10 minutes (duration of blood withdrawal)]
Differential blood count gives relative percentage of each type of white blood cell and helps reveal abnormal white blood cell populations (eg, blasts, immature granulocytes, or circulating mature cells in the peripheral blood).
Thyroid Test
时间窗: 10 minutes (duration of blood withdrawal)
Serum quantification of thyroxine, triiodothyronine, and thyroid stimulating hormone (nmol/ml) by ELISA Method
Cardiac damage
时间窗: 10 minutes (duration of blood withdrawal)
Measurement of creatine kinase myocardial band (CK-MB) concentration in serum (ImU/ml) by Colorimetric Method.
Iodine consumes
时间窗: 10 minutes (duration of urine recollection)
Measurement of iodine concentration in urine (ug/mL) by Ion Chromatography Method.
Tumor classification type and modification after treatment
时间窗: 40 minutes
Estrogen receptor (ER), Progesterone receptor (PR) and Human epidermal growth factor receptor 2 (HER2) presence in biopsy (initial) and tumor sample after treatments (final) by immunohistochemical method (number of positive cells/field).
次要结局
- Disease-free survival(Every 6 months for 5 years)
研究者
Carmen Aceves
Investigador Titular
Universidad Nacional Autonoma de Mexico