Iodine Supplementation on Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT03688958
- Lead Sponsor
- Universidad Nacional Autonoma de Mexico
- Brief Summary
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).
- Detailed Description
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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 120
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Advanced Cancer FEC/TE + Iodine 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 Advanced Cancer FEC/TE placebo 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. Early Cancer placebo 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 Early Cancer Iodine iodine The daily supplement of an iodine solution (drops, 5 mg/day) for 7 to 35 days in early breast cancer diagnosticated woman
- Primary Outcome Measures
Name Time Method Tumor response [change in size] 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]). 40 minutes Presence or not of: Edema, hand-foot syndrome, anorexia, vomiting, diarrhea, nausea, asthenia (patient interview and clinical auscultation)
Differential Blood Count 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 10 minutes (duration of blood withdrawal) Serum quantification of thyroxine, triiodothyronine, and thyroid stimulating hormone (nmol/ml) by ELISA Method
Cardiac damage 10 minutes (duration of blood withdrawal) Measurement of creatine kinase myocardial band (CK-MB) concentration in serum (ImU/ml) by Colorimetric Method.
Iodine consumes 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 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).
- Secondary Outcome Measures
Name Time Method Disease-free survival Every 6 months for 5 years The follow-up of the disease-free survival (DFS) at 5 years. (patient interview and clinical auscultation each six months)
Trial Locations
- Locations (3)
Hospital MĂ©dico TEC100
🇲🇽Querétaro City, Queretaro, Mexico
ClĂnica Hospital Dr. Ismael Vázquez Ortiz ISSSTE
🇲🇽Querétaro, Queretaro, Mexico
Hospital General Regional #1 IMSS
🇲🇽Querétaro, Queretaro, Mexico