Iodine Supplementation on Breast Cancer

National Autonomous University of Mexico ( UNAM )

Status and phase: Unknown; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Placebo; Drug: FEC/TE iodine; Drug: FEC/TE Placebo; Drug: iodine

Study type: Interventional

Funder types: Other

Identifiers

NCT03688958

ISSSTE 22-205/CEI 248/2009 (Other Identifier)

IMSS-HGR1: 185-09-03-05/MPSS (Other Identifier)

INB-UNAM-004.H

Details and patient eligibility

About

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).

Full 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).

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 81 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 4 patient groups, including a placebo group

Early Cancer placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Early Cancer Iodine

Experimental group

Description:

The daily supplement of an iodine solution (drops, 5 mg/day) for 7 to 35 days in early breast cancer diagnosticated woman

Treatment:

Drug: iodine

Advanced Cancer FEC/TE placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: FEC/TE Placebo

Advanced Cancer FEC/TE + Iodine

Experimental group

Description:

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

Treatment:

Drug: FEC/TE iodine