Male Breast CancerNCT01982591
Heavy Metal Exposure in Predicting Peripheral Neuropathy in Patients With Stage I-III Breast Cancer Undergoing Chemotherapy
An observational study of Male Breast Cancer and Neurotoxicity, run by Fox Chase Cancer Center at 2 sites in United States.
Trial summary
This research trial studies heavy metal exposure in predicting peripheral neuropathy in patients with stage I-III breast cancer undergoing chemotherapy. Studying samples of blood and urine in the laboratory for heavy metal exposure from patients receiving chemotherapy may help doctors find out whether side effects… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Male Breast Cancer, Neurotoxicity, Peripheral Neuropathy
- What is being tested?
- laboratory biomarker analysis and questionnaire administration
- How many people
- 115 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Jan 2011to 24 Mar 2015
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cancer Center
Who may be able to join
- Patients must have histologically confirmed invasive mammary carcinoma; any histologic sub-type allowed
- Patients must be diagnosed with stage I, II or III breast cancer
- Patients must be undergoing treatment with an adjuvant or neoadjuvant cytotoxic chemotherapy that includes a taxane, specifically paclitaxel, nab-paclitaxel (Abraxane), or docetaxel
- Patients may have received prior endocrine and/or radiation therapy
- Patients must have the ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Patients who have been previously treated with cytotoxic chemotherapy
- Patients with pre-existing peripheral neuropathy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Paoli Memorial Hospital
Paoli, Pennsylvania, 19301
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111-2497
About this study
Official title: Assessing Heavy Metal Contributions to Neurotoxicity in Breast Cancer Patients Undergoing Adjuvant or Neoadjuvant Chemotherapy
This research trial studies heavy metal exposure in predicting peripheral neuropathy in patients with stage I-III breast cancer undergoing chemotherapy. Studying samples of blood and urine in the laboratory for heavy metal exposure from patients receiving chemotherapy may help doctors find out whether side effects from chemotherapy are related to heavy metal exposure.
Read the detailed description
PRIMARY OBJECTIVES:
- To describe the correlation, if any, of specific heavy metals with high grade symptoms of peripheral neuropathy, defined as grade >= 3 peripheral neuropathy, (utilizing the Common Terminology Criterial for Adverse Events [CTCAE] version [v.] 4.0) in a cohort of breast cancer patients undergoing (neo)adjuvant taxane chemotherapy.
SECONDARY OBJECTIVES:
- To characterize the range of specific heavy metals in a cohort of breast cancer patients undergoing (neo)adjuvant chemotherapy treatment.
II. To evaluate the reproducibility of sera and urine testing of heavy metal levels by inductively coupled plasma mass spectrometry (ICP-MS) testing in a cohort of breast cancer patients undergoing (neo)adjuvant taxane chemotherapy.
OUTLINE:
Patients undergo serum and urine sample collection for heavy metal analysis by ICP-MS at baseline and at the completion of treatment. Patients also complete neurotoxicity assessment questionnaire at baseline and at the completion of treatment.
- Conditions
- Male Breast Cancer, Neurotoxicity, Peripheral Neuropathy, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer
- Being tested
- laboratory biomarker analysis, questionnaire administration
- Medical subject headings
- Breast Neoplasms, Male, Neurotoxicity Syndromes, Peripheral Nervous System Diseases, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory biomarker analysisOther
Correlative studies
questionnaire administrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Ancillary-Correlative (heavy metal and neurotoxicity) | Patients undergo serum and urine sample collection for heavy metal analysis by ICP-MS at baseline and at the completion of treatment. Patients also complete neurotoxicity assessment questionnaire at baseline and at the completion of treatment. Receives: Other: laboratory biomarker analysis; Other: questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of heavy metal in blood and urine
Heavy metal levels will be characterized in participants being treated at participating sites. Means and variances and ranges of these levels will be tabulated.
Measured: The levels will be measured on a blood and urine sample obtained on the first day of chemotherapy, which is considered the first day of the study. The actual laboratory processing of the samples will occur in batches throughout the duration of the study.
Incidence of high grade neurotoxicity, defined as grade >= 3 peripheral neuropathy, graded according to CTCAE v. 4.0
Neurotoxicity grade during chemotherapy will be obtained from the medical record and study doctor's notes. The maximum grade during the course of chemotherapy will be recorded. Frequencies of toxicities will be tabulated.
Measured: Last day of chemotherapy approx.4-6 months from initiation, depending on chemotherapy regimen. Neurotoxicity grade will be assessed intermittently during course of therapy, with note of maximum grade made by clinician.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study start3 Jan 2011
- Primary completion24 Mar 2015
- Study completion24 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male Breast CancerStudies of the same condition, open and under way.
- More trials run by Fox Chase Cancer CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lori Goldstein, Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01982591
- Sponsor's protocol ID
- ERP-BR-059
- Other IDs
- NCI-2013-01957, IRB#10-039, BR-059, ERP-BR-059, P30CA006927
- Status last verified
- Jun 2017
- First submitted
- 24 Oct 2013
- Last updated
- 15 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Heavy Metal Contributions to Neurotoxicity in Breast Cancer Patients Undergoing Adjuvant or Neoadjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT01982591
- Acronym / sponsor ID
- ERP-BR-059
- Conditions
- Male Breast Cancer, Neurotoxicity, Peripheral Neuropathy, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 3 Jan 2011 (actual)
- Primary completion
- 24 Mar 2015 (actual)
- Study completion
- 24 Mar 2015 (actual)
- First posted
- 13 Nov 2013 (estimated)
- 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.
This research trial studies heavy metal exposure in predicting peripheral neuropathy in patients with stage I-III breast cancer undergoing chemotherapy. Studying samples of blood and urine in the laboratory for heavy metal exposure from patients receiving chemotherapy may help doctors find out whether side effects from chemotherapy are related to heavy metal exposure.
Detailed description
PRIMARY OBJECTIVES:
- To describe the correlation, if any, of specific heavy metals with high grade symptoms of peripheral neuropathy, defined as grade >= 3 peripheral neuropathy, (utilizing the Common Terminology Criterial for Adverse Events [CTCAE] version [v.] 4.0) in a cohort of breast cancer patients undergoing (neo)adjuvant taxane chemotherapy.
SECONDARY OBJECTIVES:
- To characterize the range of specific heavy metals in a cohort of breast cancer patients undergoing (neo)adjuvant chemotherapy treatment.
II. To evaluate the reproducibility of sera and urine testing of heavy metal levels by inductively coupled plasma mass spectrometry (ICP-MS) testing in a cohort of breast cancer patients undergoing (neo)adjuvant taxane chemotherapy.
OUTLINE:
Patients undergo serum and urine sample collection for heavy metal analysis by ICP-MS at baseline and at the completion of treatment. Patients also complete neurotoxicity assessment questionnaire at baseline and at the completion of treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ancillary-Correlative (heavy metal and neurotoxicity) | – | Other: laboratory biomarker analysis, Other: questionnaire administrationPatients undergo serum and urine sample collection for heavy metal analysis by ICP-MS at baseline and at the completion of treatment. Patients also complete neurotoxicity assessment questionnaire at baseline and at the completion of treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer Center
Key inclusion criteria (5 listed)
- Patients must have histologically confirmed invasive mammary carcinoma; any histologic sub-type allowed
- Patients must be diagnosed with stage I, II or III breast cancer
- Patients must be undergoing treatment with an adjuvant or neoadjuvant cytotoxic chemotherapy that includes a taxane, specifically paclitaxel, nab-paclitaxel (Abraxane), or docetaxel
- Patients may have received prior endocrine and/or radiation therapy
- Patients must have the ability to understand and the willingness to sign a written informed consent document
Key exclusion criteria (2 listed)
- Patients who have been previously treated with cytotoxic chemotherapy
- Patients with pre-existing peripheral neuropathy
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 |
|---|---|---|
| laboratory biomarker analysisCorrelative studies | Other | Ancillary-Correlative (heavy metal and neurotoxicity) |
| questionnaire administrationAncillary studies | Other | Ancillary-Correlative (heavy metal and neurotoxicity) |
Primary outcome
Level of heavy metal in blood and urine
Time frame: The levels will be measured on a blood and urine sample obtained on the first day of chemotherapy, which is considered the first day of the study. The actual laboratory processing of the samples will occur in batches throughout the duration of the study.
Heavy metal levels will be characterized in participants being treated at participating sites. Means and variances and ranges of these levels will be tabulated.
Incidence of high grade neurotoxicity, defined as grade >= 3 peripheral neuropathy, graded according to CTCAE v. 4.0
Time frame: Last day of chemotherapy approx.4-6 months from initiation, depending on chemotherapy regimen. Neurotoxicity grade will be assessed intermittently during course of therapy, with note of maximum grade made by clinician.
Neurotoxicity grade during chemotherapy will be obtained from the medical record and study doctor's notes. The maximum grade during the course of chemotherapy will be recorded. Frequencies of toxicities will be tabulated.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2017.
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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.
Lori Goldstein principal investigator
Fox Chase Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Male Breast Cancer and Neurotoxicity, run by Fox Chase Cancer Center at 2 sites in United States.
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 15 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of heavy metal in blood and urine (time frame: The levels will be measured on a blood and urine sample obtained on the first day of chemotherapy, which is considered the first day of the study. The actual laboratory processing of the samples will occur in batches throughout the duration of the study.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jun 2017.