NCT03688958

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline
Completed

Started Mar 2005

Longer than P75 for phase_2 breast-cancer

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2005

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
8.8 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

September 28, 2018

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

September 28, 2018

Status Verified

September 1, 2018

Enrollment Period

4.7 years

First QC Date

August 31, 2018

Last Update Submit

September 26, 2018

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (7)

  • Tumor response [change in size]

    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.

    20 minutes

  • Incidence of treatment-emergent adverse events [Safety and Tolerability]).

    Presence or not of: Edema, hand-foot syndrome, anorexia, vomiting, diarrhea, nausea, asthenia (patient interview and clinical auscultation)

    40 minutes

  • Differential Blood Count

    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).

    10 minutes (duration of blood withdrawal)]

  • Thyroid Test

    Serum quantification of thyroxine, triiodothyronine, and thyroid stimulating hormone (nmol/ml) by ELISA Method

    10 minutes (duration of blood withdrawal)

  • Cardiac damage

    Measurement of creatine kinase myocardial band (CK-MB) concentration in serum (ImU/ml) by Colorimetric Method.

    10 minutes (duration of blood withdrawal)

  • Iodine consumes

    Measurement of iodine concentration in urine (ug/mL) by Ion Chromatography Method.

    10 minutes (duration of urine recollection)

  • Tumor classification type and modification after treatment

    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).

    40 minutes

Secondary Outcomes (1)

  • Disease-free survival

    Every 6 months for 5 years

Study Arms (4)

Early Cancer placebo

PLACEBO COMPARATOR

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

Early Cancer Iodine

EXPERIMENTAL

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

Drug: iodine

Advanced Cancer FEC/TE placebo

PLACEBO COMPARATOR

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

Advanced Cancer FEC/TE + Iodine

EXPERIMENTAL

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

Interventions

PlaceboDRUG

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).

Also known as: control
Early Cancer placebo
iodineDRUG

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).

Also known as: experimental
Early Cancer Iodine
FEC/TE PlaceboDRUG

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).

Advanced Cancer FEC/TE placebo
FEC/TE iodineDRUG

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).

Advanced Cancer FEC/TE + Iodine

Eligibility Criteria

Age18 Years - 81 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital Médico TEC100

Querétaro City, Querétaro, 76000, Mexico

RECRUITING

Clínica Hospital Dr. Ismael Vázquez Ortiz ISSSTE

Querétaro City, Querétaro, 76001, Mexico

RECRUITING

Hospital General Regional #1 IMSS

Querétaro City, Querétaro, 76001, Mexico

RECRUITING

Related Publications (6)

  • Zambrano-Estrada X, Landaverde-Quiroz B, Duenas-Bocanegra AA, De Paz-Campos MA, Hernandez-Alberto G, Solorio-Perusquia B, Trejo-Mandujano M, Perez-Guerrero L, Delgado-Gonzalez E, Anguiano B, Aceves C. Molecular iodine/doxorubicin neoadjuvant treatment impair invasive capacity and attenuate side effect in canine mammary cancer. BMC Vet Res. 2018 Mar 12;14(1):87. doi: 10.1186/s12917-018-1411-6.

    PMID: 29530037RESULT

  • Bontempo A, Ugalde-Villanueva B, Delgado-Gonzalez E, Rodriguez AL, Aceves C. Molecular iodine impairs chemoresistance mechanisms, enhances doxorubicin retention and induces downregulation of the CD44+/CD24+ and E-cadherin+/vimentin+ subpopulations in MCF-7 cells resistant to low doses of doxorubicin. Oncol Rep. 2017 Nov;38(5):2867-2876. doi: 10.3892/or.2017.5934. Epub 2017 Sep 1.

    PMID: 28901484RESULT

  • Nava-Villalba M, Nunez-Anita RE, Bontempo A, Aceves C. Activation of peroxisome proliferator-activated receptor gamma is crucial for antitumoral effects of 6-iodolactone. Mol Cancer. 2015 Sep 17;14:168. doi: 10.1186/s12943-015-0436-8.

    PMID: 26376791RESULT

  • Alfaro Y, Delgado G, Carabez A, Anguiano B, Aceves C. Iodine and doxorubicin, a good combination for mammary cancer treatment: antineoplastic adjuvancy, chemoresistance inhibition, and cardioprotection. Mol Cancer. 2013 May 24;12:45. doi: 10.1186/1476-4598-12-45.

    PMID: 23705792RESULT

  • Aceves C, Anguiano B, Delgado G. The extrathyronine actions of iodine as antioxidant, apoptotic, and differentiation factor in various tissues. Thyroid. 2013 Aug;23(8):938-46. doi: 10.1089/thy.2012.0579.

    PMID: 23607319RESULT

  • Garcia-Solis P, Alfaro Y, Anguiano B, Delgado G, Guzman RC, Nandi S, Diaz-Munoz M, Vazquez-Martinez O, Aceves C. Inhibition of N-methyl-N-nitrosourea-induced mammary carcinogenesis by molecular iodine (I2) but not by iodide (I-) treatment Evidence that I2 prevents cancer promotion. Mol Cell Endocrinol. 2005 May 31;236(1-2):49-57. doi: 10.1016/j.mce.2005.03.001. Epub 2005 Apr 13.

    PMID: 15922087RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Iodine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

HalogensElementsInorganic Chemicals

Study Officials

  • Carmen Aceves, PhD

    Universidad Nacional Autonoma de Mexico

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carmen Aceves, PhD

CONTACT

52 442 2381067caracev@unam.mx

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
double blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigador Titular

Study Record Dates

First Submitted

August 31, 2018

First Posted

September 28, 2018

Study Start

March 15, 2005

Primary Completion

December 1, 2009

Study Completion

June 1, 2020

Last Updated

September 28, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will share

De-identified individual participant data for all primarily and secondary outcome measures will be made available

Shared Documents
STUDY PROTOCOL, SAP, ICF, 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

Locations

ME(3)