Breast CancerPhase 2NCT03688958
Iodine Supplementation on Breast Cancer
A Phase 2 study testing iodine and FEC/TE iodine in people with Breast Cancer, run by Universidad Nacional Autonoma de Mexico at 3 sites in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 81 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- iodine and FEC/TE iodine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 3 sitesMexico
- Study dates
- 15 Mar 2005to Jun 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 81 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Mexico3 sites, 3 recruiting
- Recruiting
Hospital Médico TEC100
Querétaro City, Querétaro, 76000
Guillermo Peralta Castillo, MD, 524424699698, drmemop@gmail.com
- Recruiting
Clínica Hospital Dr. Ismael Vázquez Ortiz ISSSTE
Querétaro City, Querétaro, 76001
Carlos Avecilla, MD, 442 2154944, drcavecilla@gmail.com
Jose Miguel Torres-Martel, MD, 524422381067, jmiguelmex@hotmail.com
- Recruiting
Hospital General Regional #1 IMSS
Querétaro City, Querétaro, 76001
Joel Rojas, Md, 52 442 216 26 62, joelro_onco@hotmail.com
Guillermo Peralta, MD, 524422381067, drmemop@gmail.com
About this study
Official title: Effect of Dietary Iodine Supplementation on the Proliferation of Breast Cancer
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).
Read the 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).
- Conditions
- Breast Cancer
- Being tested
- Placebo, iodine, FEC/TE Placebo, FEC/TE iodine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called control
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).
iodineDrug
Also called experimental
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).
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).
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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. Receives: 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 Receives: Drug: FEC/TE iodine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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).
Measured: 10 minutes (duration of blood withdrawal)]
Thyroid Test
Serum quantification of thyroxine, triiodothyronine, and thyroid stimulating hormone (nmol/ml) by ELISA Method
Measured: 10 minutes (duration of blood withdrawal)
Cardiac damage
Measurement of creatine kinase myocardial band (CK-MB) concentration in serum (ImU/ml) by Colorimetric Method.
Measured: 10 minutes (duration of blood withdrawal)
Iodine consumes
Measurement of iodine concentration in urine (ug/mL) by Ion Chromatography Method.
Measured: 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).
Measured: 40 minutes
Secondary outcomes (1)
Disease-free survival
The follow-up of the disease-free survival (DFS) at 5 years. (patient interview and clinical auscultation each six months)
Measured: Every 6 months for 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start15 Mar 2005
- Primary completion1 Dec 2009
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional Autonoma de Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital General Regional #1 IMSS, Queretaro México, Clínica Hospital Dr. Ismael Vázquez Ortiz ISSSTE, Queretaro Mexico, Hospital Medico TEC100, Queretaro México
- Responsible party
- Principal investigator, Carmen Aceves, Universidad Nacional Autonoma de Mexico
- Investigators
- Carmen Aceves, PhD, Principal investigator, Universidad Nacional Autonoma de Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03688958
- Sponsor's protocol ID
- INB-UNAM-004.H
- Other IDs
- IMSS-HGR1: 185-09-03-05/MPSS, ISSSTE 22-205/CEI 248/2009
- Status last verified
- Sep 2018
- First submitted
- 31 Aug 2018
- Last updated
- 28 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primarily and secondary outcome measures will be made available
Publications
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.
PubMed 29530037Bontempo 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.
PubMed 28901484Nava-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.
PubMed 26376791Alfaro 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.
PubMed 23705792Aceves 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.
PubMed 23607319Garcia-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.
PubMed 15922087
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dietary Iodine Supplementation on the Proliferation of Breast Cancer
- ClinicalTrials.gov ID
- NCT03688958
- Acronym / sponsor ID
- INB-UNAM-004.H
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Universidad Nacional Autonoma de MexicoUniversity, hospital or other
- Collaborators
- Hospital General Regional #1 IMSS, Queretaro México, Clínica Hospital Dr. Ismael Vázquez Ortiz ISSSTE, Queretaro Mexico, Hospital Medico TEC100, Queretaro México
- Study start
- 15 Mar 2005 (actual)
- Primary completion
- 1 Dec 2009 (actual)
- Study completion
- Jun 2020 (estimated)
- First posted
- 28 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Early Cancer placebo | Placebo comparator | Drug: PlaceboThe 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 |
| Early Cancer Iodine | Experimental | Drug: iodineThe daily supplement of an iodine solution (drops, 5 mg/day) for 7 to 35 days in early breast cancer diagnosticated woman |
| Advanced Cancer FEC/TE placebo | Placebo comparator | Drug: FEC/TE PlaceboThe 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. |
| Advanced Cancer FEC/TE + Iodine | Experimental | Drug: FEC/TE iodineThe 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 |
Who may qualify
- Ages
- 18 to 81 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboAlso: controlSelected 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 | Early Cancer placebo |
| iodineAlso: experimentalSelected 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 | Early Cancer Iodine |
| FEC/TE PlaceboThe 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 | Advanced Cancer FEC/TE placebo |
| FEC/TE iodineThe 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). | Drug | Advanced Cancer FEC/TE + Iodine |
Primary outcome
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).
1 secondary outcome
Disease-free survival
Time frame: Every 6 months for 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2018.
- Results publication: PubMed 29530037Zambrano-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.
- Results publication: PubMed 28901484Bontempo 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.
- Results publication: PubMed 26376791Nava-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.
- Results publication: PubMed 23705792Alfaro 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.
- Results publication: PubMed 23607319Aceves 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.
- Results publication: PubMed 15922087Garcia-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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primarily and secondary outcome measures will be made available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmen Aceves, PhD principal investigator
Universidad Nacional Autonoma de Mexico
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing iodine and FEC/TE iodine in people with Breast Cancer, run by Universidad Nacional Autonoma de Mexico at 3 sites in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carmen Aceves, PhD (52 442 2381067, caracev@unam.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor response [change in size] (time frame: 20 minutes). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03688958, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2018.