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Iodine Supplementation on Breast Cancer

NCT03688958 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2018-09-28

No results posted yet for this study

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).

Conditions

Interventions

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).

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).

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).

Sponsors & Collaborators

  • Hospital General Regional #1 IMSS, Queretaro México

    collaborator UNKNOWN

  • Clínica Hospital Dr. Ismael Vázquez Ortiz ISSSTE, Queretaro Mexico

    collaborator UNKNOWN

  • Hospital Medico TEC100, Queretaro México

    collaborator UNKNOWN

  • Universidad Nacional Autonoma de Mexico

    lead OTHER

Principal Investigators

  • Carmen Aceves, PhD · Universidad Nacional Autonoma de Mexico

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
81 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-03-15
Primary Completion
2009-12-01
Completion
2020-06-30

Countries

  • Mexico

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03688958 on ClinicalTrials.gov