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Iodine Supplementation on Breast Cancer

NCT ID: NCT03688958

Last Updated: 2018-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-15

Study Completion Date

2020-06-30

Brief Summary

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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

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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).

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
double blind

Study Groups

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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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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).

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

Group Type EXPERIMENTAL

iodine

Intervention Type DRUG

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).

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.

Group Type PLACEBO_COMPARATOR

FEC/TE Placebo

Intervention Type DRUG

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 + 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

Group Type EXPERIMENTAL

FEC/TE iodine

Intervention Type DRUG

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).

Interventions

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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).

Intervention Type 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).

Intervention Type 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).

Intervention Type 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).

Intervention Type DRUG

Other Intervention Names

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control experimental

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

81 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospital General Regional #1 IMSS, Queretaro México

UNKNOWN

Sponsor Role collaborator

Clínica Hospital Dr. Ismael Vázquez Ortiz ISSSTE, Queretaro Mexico

UNKNOWN

Sponsor Role collaborator

Hospital Medico TEC100, Queretaro México

UNKNOWN

Sponsor Role collaborator

Universidad Nacional Autonoma de Mexico

OTHER

Sponsor Role lead

Responsible Party

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Carmen Aceves

Investigador Titular

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carmen Aceves, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad Nacional Autonoma de Mexico

Locations

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Hospital Médico TEC100

Querétaro City, Querétaro, Mexico

Site Status RECRUITING

Clínica Hospital Dr. Ismael Vázquez Ortiz ISSSTE

Querétaro City, Querétaro, Mexico

Site Status RECRUITING

Hospital General Regional #1 IMSS

Querétaro City, Querétaro, Mexico

Site Status RECRUITING

Countries

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Mexico

Central Contacts

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Carmen Aceves, PhD

Role: CONTACT

Phone: 52 442 2381067

Email: [email protected]

Facility Contacts

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Guillermo Peralta Castillo, MD

Role: primary

Carlos Avecilla, MD

Role: primary

Jose Miguel Torres-Martel, MD

Role: backup

Joel Rojas, Md

Role: primary

Guillermo Peralta, MD

Role: backup

References

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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.

Reference Type RESULT
PMID: 29530037 (View on PubMed)

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.

Reference Type RESULT
PMID: 28901484 (View on PubMed)

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.

Reference Type RESULT
PMID: 26376791 (View on PubMed)

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.

Reference Type RESULT
PMID: 23705792 (View on PubMed)

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.

Reference Type RESULT
PMID: 23607319 (View on PubMed)

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.

Reference Type RESULT
PMID: 15922087 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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IMSS-HGR1: 185-09-03-05/MPSS

Identifier Type: OTHER

Identifier Source: secondary_id

ISSSTE 22-205/CEI 248/2009

Identifier Type: OTHER

Identifier Source: secondary_id

INB-UNAM-004.H

Identifier Type: -

Identifier Source: org_study_id