Iodine Supplementation on Breast Cancer
Breast Cancer
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Hospital Médico TEC100Recruiting
- Clínica Hospital Dr. Ismael Vázquez Ortiz ISSSTERecruiting
- Hospital General Regional #1 IMSSRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Early Cancer placebo
Early Cancer Iodine
Advanced Cancer FEC/TE placebo
Advanced Cancer FEC/TE + Iodine
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
The daily supplement of an iodine solution (drops, 5 mg/day) for 7 to 35 days in early breast cancer diagnosticated woman
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.
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