Iodine Supplementation on Breast Cancer
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ClinicalTrials.gov Identifier: NCT03688958 |
Recruitment Status : Unknown
Verified September 2018 by Carmen Aceves, Universidad Nacional Autonoma de Mexico.
Recruitment status was: Recruiting
First Posted : September 28, 2018
Last Update Posted : September 28, 2018
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Condition or disease | Intervention/treatment | Phase |
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Breast Cancer | Drug: Placebo Drug: iodine Drug: FEC/TE Placebo Drug: FEC/TE iodine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | 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. |
Masking: | Triple (Participant, Care Provider, Investigator) |
Masking Description: | double blind |
Primary Purpose: | Treatment |
Official Title: | Effect of Dietary Iodine Supplementation on the Proliferation of Breast Cancer |
Actual Study Start Date : | March 15, 2005 |
Actual Primary Completion Date : | December 1, 2009 |
Estimated Study Completion Date : | June 2020 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: 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 |
Drug: Placebo
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).
Other Name: control |
Experimental: 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
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Drug: iodine
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).
Other Name: experimental |
Placebo Comparator: 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. |
Drug: FEC/TE Placebo
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). |
Experimental: 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 |
Drug: FEC/TE iodine
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). |
- Tumor response [change in size] [ Time Frame: 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]). [ Time Frame: 40 minutes ]Presence or not of: Edema, hand-foot syndrome, anorexia, vomiting, diarrhea, nausea, asthenia (patient interview and clinical auscultation)
- Differential Blood Count [ Time Frame: 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 [ Time Frame: 10 minutes (duration of blood withdrawal) ]Serum quantification of thyroxine, triiodothyronine, and thyroid stimulating hormone (nmol/ml) by ELISA Method
- Cardiac damage [ Time Frame: 10 minutes (duration of blood withdrawal) ]Measurement of creatine kinase myocardial band (CK-MB) concentration in serum (ImU/ml) by Colorimetric Method.
- Iodine consumes [ Time Frame: 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 [ Time Frame: 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).
- Disease-free survival [ Time Frame: 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)

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Ages Eligible for Study: | 18 Years to 81 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03688958
Contact: Carmen Aceves, PhD | 52 442 2381067 | caracev@unam.mx |
Mexico | |
Hospital Médico TEC100 | Recruiting |
Querétaro City, Queretaro, Mexico, 76000 | |
Contact: Guillermo Peralta Castillo, MD 524424699698 drmemop@gmail.com | |
Clínica Hospital Dr. Ismael Vázquez Ortiz ISSSTE | Recruiting |
Querétaro, Queretaro, Mexico, 76001 | |
Contact: Carlos Avecilla, MD 442 2154944 drcavecilla@gmail.com | |
Contact: Jose Miguel Torres-Martel, MD 524422381067 jmiguelmex@hotmail.com | |
Hospital General Regional #1 IMSS | Recruiting |
Querétaro, Queretaro, Mexico, 76001 | |
Contact: Joel Rojas, Md 52 442 216 26 62 joelro_onco@hotmail.com | |
Contact: Guillermo Peralta, MD 524422381067 drmemop@gmail.com |
Principal Investigator: | Carmen Aceves, PhD | Universidad Nacional Autonoma de Mexico |
Documents provided by Carmen Aceves, Universidad Nacional Autonoma de Mexico:
Responsible Party: | Carmen Aceves, Investigador Titular, Universidad Nacional Autonoma de Mexico |
ClinicalTrials.gov Identifier: | NCT03688958 |
Other Study ID Numbers: |
INB-UNAM-004.H IMSS-HGR1: 185-09-03-05/MPSS ( Other Identifier: Hospital General Regional #1 IMSS ) ISSSTE 22-205/CEI 248/2009 ( Other Identifier: Clínica Hospital Dr. Ismael Vázquez Ortiz ISSSTE ) |
First Posted: | September 28, 2018 Key Record Dates |
Last Update Posted: | September 28, 2018 |
Last Verified: | September 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | De-identified individual participant data for all primarily and secondary outcome measures will be made available |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code |
Time Frame: | Data will be available within 12 months of study completion |
Access Criteria: | Requestors will be required to sign a data access agreement |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Iodine Cadexomer iodine |
Anti-Infective Agents, Local Anti-Infective Agents Trace Elements Micronutrients Nutrients Growth Substances Physiological Effects of Drugs |