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Iodine Supplementation on Breast Cancer

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ClinicalTrials.gov Identifier: NCT03688958
Recruitment Status : Recruiting
First Posted : September 28, 2018
Last Update Posted : September 28, 2018
Sponsor:
Collaborators:
Hospital General Regional #1 IMSS, Queretaro México
Clínica Hospital Dr. Ismael Vázquez Ortiz ISSSTE, Queretaro Mexico
Hospital Medico TEC100, Queretaro México
Information provided by (Responsible Party):
Carmen Aceves, Universidad Nacional Autonoma de Mexico

Study Description
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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).

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Placebo Drug: iodine Drug: FEC/TE Placebo Drug: FEC/TE iodine Phase 2

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).

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Iodine

Arms and Interventions
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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
 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).


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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)

  3. 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).

  4. Thyroid Test [ Time Frame: 10 minutes (duration of blood withdrawal) ]
    Serum quantification of thyroxine, triiodothyronine, and thyroid stimulating hormone (nmol/ml) by ELISA Method

  5. 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.

  6. Iodine consumes [ Time Frame: 10 minutes (duration of urine recollection) ]
    Measurement of iodine concentration in urine (ug/mL) by Ion Chromatography Method.

  7. 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).


Secondary Outcome Measures :
  1. 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)


Eligibility Criteria
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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
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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Carmen Aceves, PhD 52 442 2381067 caracev@unam.mx

Locations
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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   
Sponsors and Collaborators
Universidad Nacional Autonoma de Mexico
Hospital General Regional #1 IMSS, Queretaro México
Clínica Hospital Dr. Ismael Vázquez Ortiz ISSSTE, Queretaro Mexico
Hospital Medico TEC100, Queretaro México
Investigators
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Principal Investigator: Carmen Aceves, PhD Universidad Nacional Autonoma de Mexico
  Study Documents (Full-Text)

Documents provided by Carmen Aceves, Universidad Nacional Autonoma de Mexico:
Informed Consent Form  [PDF] December 1, 2009

More Information
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Publications of Results:

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Responsible Party: Carmen Aceves, Investigador Titular, Universidad Nacional Autonoma de Mexico
ClinicalTrials.gov Identifier: NCT03688958     History of Changes
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

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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

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Pharmaceutical Solutions
Iodine
Cadexomer iodine
 Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs