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
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Placebo Drug: iodine Drug: FEC/TE Placebo Drug: FEC/TE iodine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|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|
|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|
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
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
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).
- 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).
- 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)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03688958
|Contact: Carmen Aceves, PhD||52 442 firstname.lastname@example.org|
|Hospital Médico TEC100||Recruiting|
|Querétaro City, Queretaro, Mexico, 76000|
|Contact: Guillermo Peralta Castillo, MD 524424699698 email@example.com|
|Clínica Hospital Dr. Ismael Vázquez Ortiz ISSSTE||Recruiting|
|Querétaro, Queretaro, Mexico, 76001|
|Contact: Carlos Avecilla, MD 442 2154944 firstname.lastname@example.org|
|Contact: Jose Miguel Torres-Martel, MD 524422381067 email@example.com|
|Hospital General Regional #1 IMSS||Recruiting|
|Querétaro, Queretaro, Mexico, 76001|
|Contact: Joel Rojas, Md 52 442 216 26 62 firstname.lastname@example.org|
|Contact: Guillermo Peralta, MD 524422381067 email@example.com|
|Principal Investigator:||Carmen Aceves, PhD||Universidad Nacional Autonoma de Mexico|