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).
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
120
Selected patients with early breast cancer (stage II) non-pretreated received colored water solution (placebo) within the time before the hospital assigned them to her surgery (7 to 35 days).
Selected patients with early breast cancer (stage II) non-pretreated received iodine solution (Experimental) within the time before the hospital assigned them to her surgery (7 to 35 days).
The selected patients with advanced breast cancer (stage III) non-pretreated received colored water solution (placebo) within the time of oncology designed chemotherapy treatment FEC/TE (4 or 6 cycles/ every 21 days).
Hospital Médico TEC100
Querétaro City, Querétaro, Mexico
RECRUITINGClínica Hospital Dr. Ismael Vázquez Ortiz ISSSTE
Querétaro City, Querétaro, Mexico
RECRUITINGHospital General Regional #1 IMSS
Querétaro City, Querétaro, Mexico
RECRUITINGTumor response [change in size]
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.
Time frame: 20 minutes
Incidence of treatment-emergent adverse events [Safety and Tolerability]).
Presence or not of: Edema, hand-foot syndrome, anorexia, vomiting, diarrhea, nausea, asthenia (patient interview and clinical auscultation)
Time frame: 40 minutes
Differential Blood Count
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).
Time frame: 10 minutes (duration of blood withdrawal)]
Thyroid Test
Serum quantification of thyroxine, triiodothyronine, and thyroid stimulating hormone (nmol/ml) by ELISA Method
Time frame: 10 minutes (duration of blood withdrawal)
Cardiac damage
Measurement of creatine kinase myocardial band (CK-MB) concentration in serum (ImU/ml) by Colorimetric Method.
Time frame: 10 minutes (duration of blood withdrawal)
Iodine consumes
Measurement of iodine concentration in urine (ug/mL) by Ion Chromatography Method.
Time frame: 10 minutes (duration of urine recollection)
Tumor classification type and modification after treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The selected patients with advanced breast cancer (stage III) non-pretreated received iodine solution (experimental) within the time of oncology designed chemotherapy treatment (4 or 6 cycles/ every 21 days).
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).
Time frame: 40 minutes
Disease-free survival
The follow-up of the disease-free survival (DFS) at 5 years. (patient interview and clinical auscultation each six months)
Time frame: Every 6 months for 5 years