NeurotoxicityNCT00281853
Nerve Changes in Patients Who Are Undergoing Chemotherapy or Biological Therapy for Cancer
An observational study of Neurotoxicity and Unspecified Adult Solid Tumor, Protocol Specific, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Learning about the effects of chemotherapy and biological therapy on nerve function may help doctors plan treatment and help patients live more comfortably. PURPOSE: This clinical trial is studying peripheral neuropathy in patients who are receiving chemotherapy or biological therapy for cancer. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Neurotoxicity, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- management of therapy complications
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Aug 2007
- 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 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are receiving chemotherapy or biological therapy for cancer.
DISEASE CHARACTERISTICS:
- Histologically confirmed diagnosis of cancer
- Scheduled to be treated with 1 of the following agents:
- Cisplatin/paclitaxel combination
- Biologic therapy with high-dose interferon alfa
PATIENT CHARACTERISTICS:
- Normal vision OR vision corrected with glasses or contact lenses
- No diseases or disorders reducing peripheral nerve function, including any of the following:
- Diabetes mellitus
- HIV/AIDS
- Uremia
- Spinal injuries
- Alcoholism
- CNS problems
- No hearing impairment
PRIOR CONCURRENT THERAPY:
- No prior biologic therapy or neurotoxic chemotherapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
About this study
Official title: Characterization of Chemotherapy/Biotherapy-Induced Peripheral Neuropathy: Refinement of Clinical Measures
RATIONALE: Learning about the effects of chemotherapy and biological therapy on nerve function may help doctors plan treatment and help patients live more comfortably.
PURPOSE: This clinical trial is studying peripheral neuropathy in patients who are receiving chemotherapy or biological therapy for cancer.
Read the detailed description
OBJECTIVES:
- Determine the change in peripheral nerve function in cancer patients during and after treatment with chemotherapy or biologic therapy.
- Determine the clinical measurement of hearing-related air and bone conduction and vibratory sensation in these patients.
- Correlate the changes in orthostatic blood pressure using both the Vasotrac automated blood pressure device and the standard clinical automated blood pressure equipment.
- Determine the patient's perception of hearing quality before and after treatment with chemotherapy or biologic therapy.
OUTLINE: This is a multicenter study.
Patients undergo a 1-hour peripheral nerve function assessment, including hearing, vibratory sensation, and blood pressure testing, at baseline and then at 4, 8, and 12 weeks during treatment with chemotherapy or biologic therapy.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
- Being tested
- management of therapy complications
- Keywords
- neurotoxicity, unspecified adult solid tumor, protocol specific
- Medical subject headings
- Neurotoxicity Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
management of therapy complicationsProcedure or surgery
Patients undergo a 1-hour peripheral nerve function assessment, including hearing, vibratory sensation, and blood pressure testing, at baseline and then at 4, 8, and 12 weeks during treatment with chemotherapy or biologic therapy.
What is being measured
The primary outcome is the main question the study is designed to answer.
Hearing as measured by the Weber test and the Rinne test at baseline, and then weeks 4, 8, and 12 during study treatment
Measured: baseline, and then weeks 4, 8, and 12 during study treatment
Vibratory sensation as measured by tuning fork at baseline, and then weeks 4, 8, and 12 during study treatment
Measured: baseline, and then weeks 4, 8, and 12 during study treatment
Blood pressure changes at baseline, and then weeks 4, 8, and 12 during study treatment
Measured: baseline, and then weeks 4, 8, and 12 during study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2006 (estimated)
- Study startMar 2005
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeurotoxicityStudies of the same condition, open and under way.
- More trials run by Case Comprehensive 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Constance Visovsky, PhD, Principal investigator, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00281853
- Sponsor's protocol ID
- CASE13Z04
- Other IDs
- P30CA043703, CASE-13Z04, CASE-120411
- Status last verified
- Jun 2010
- First submitted
- 24 Jan 2006
- Last updated
- 11 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Chemotherapy/Biotherapy-Induced Peripheral Neuropathy: Refinement of Clinical Measures
- ClinicalTrials.gov ID
- NCT00281853
- Acronym / sponsor ID
- CASE13Z04
- Keywords
- neurotoxicity, unspecified adult solid tumor, protocol specific
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2005
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 25 Jan 2006 (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.
RATIONALE: Learning about the effects of chemotherapy and biological therapy on nerve function may help doctors plan treatment and help patients live more comfortably.
PURPOSE: This clinical trial is studying peripheral neuropathy in patients who are receiving chemotherapy or biological therapy for cancer.
Detailed description
OBJECTIVES:
- Determine the change in peripheral nerve function in cancer patients during and after treatment with chemotherapy or biologic therapy.
- Determine the clinical measurement of hearing-related air and bone conduction and vibratory sensation in these patients.
- Correlate the changes in orthostatic blood pressure using both the Vasotrac automated blood pressure device and the standard clinical automated blood pressure equipment.
- Determine the patient's perception of hearing quality before and after treatment with chemotherapy or biologic therapy.
OUTLINE: This is a multicenter study.
Patients undergo a 1-hour peripheral nerve function assessment, including hearing, vibratory sensation, and blood pressure testing, at baseline and then at 4, 8, and 12 weeks during treatment with chemotherapy or biologic therapy.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are receiving chemotherapy or biological therapy for cancer.
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 |
|---|---|---|
| management of therapy complicationsPatients undergo a 1-hour peripheral nerve function assessment, including hearing, vibratory sensation, and blood pressure testing, at baseline and then at 4, 8, and 12 weeks during treatment with chemotherapy or biologic therapy. | Procedure or surgery | – |
Primary outcome
Hearing as measured by the Weber test and the Rinne test at baseline, and then weeks 4, 8, and 12 during study treatment
Time frame: baseline, and then weeks 4, 8, and 12 during study treatment
Vibratory sensation as measured by tuning fork at baseline, and then weeks 4, 8, and 12 during study treatment
Time frame: baseline, and then weeks 4, 8, and 12 during study treatment
Blood pressure changes at baseline, and then weeks 4, 8, and 12 during study treatment
Time frame: baseline, and then weeks 4, 8, and 12 during study treatment
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 11 Jun 2010.
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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.
Constance Visovsky, PhD principal investigator
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurotoxicity and Unspecified Adult Solid Tumor, Protocol Specific, run by Case Comprehensive Cancer Center at 1 site 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?
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 11 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Hearing as measured by the Weber test and the Rinne test at baseline, and then weeks 4, 8, and 12 during study treatment (time frame: baseline, and then weeks 4, 8, and 12 during study treatment). The study lists 3 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 11 Jun 2010.