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Trial record 6 of 190 for:    Oral Cancer | ( Map: Mexico )

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

Tracking Information
First Submitted Date  ICMJE August 31, 2018
First Posted Date  ICMJE September 28, 2018
Last Update Posted Date September 28, 2018
Actual Study Start Date  ICMJE March 15, 2005
Actual Primary Completion Date December 1, 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2018)
  • 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2018)
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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Iodine Supplementation on Breast Cancer
Official Title  ICMJE Effect of Dietary Iodine Supplementation on the Proliferation of Breast Cancer
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • 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
  • 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
  • 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).
  • 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).
Study Arms  ICMJE
  • 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

    Intervention: Drug: Placebo
  • 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
    Intervention: Drug: iodine
  • 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.

    Intervention: Drug: FEC/TE Placebo
  • 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

    Intervention: Drug: FEC/TE iodine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 26, 2018)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Actual Primary Completion Date December 1, 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 81 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Carmen Aceves, PhD 52 442 2381067 caracev@unam.mx
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03688958
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: 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
Responsible Party Carmen Aceves, Universidad Nacional Autonoma de Mexico
Study Sponsor  ICMJE Universidad Nacional Autonoma de Mexico
Collaborators  ICMJE
  • Hospital General Regional #1 IMSS, Queretaro México
  • Clínica Hospital Dr. Ismael Vázquez Ortiz ISSSTE, Queretaro Mexico
  • Hospital Medico TEC100, Queretaro México
Investigators  ICMJE
Principal Investigator: Carmen Aceves, PhD Universidad Nacional Autonoma de Mexico
PRS Account Universidad Nacional Autonoma de Mexico
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP