Acupuncture in Treating Nerve Pain in Patients With Stage I, Stage II, or Stage III Breast Cancer Who Are Receiving Paclitaxel
NCT ID: NCT01050075
Last Updated: 2017-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
7 participants
INTERVENTIONAL
2010-01-31
2012-05-31
Brief Summary
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PURPOSE: This randomized clinical trial is studying how well acupuncture works in treating nerve pain in patients with stage I, stage II, and stage III breast cancer who are receiving paclitaxel.
Detailed Description
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I. To explore the potential for the use of acupuncture to prevent a worsening of the nerve damage in patients (during treatment) due to paclitaxel as measured by a Neuropathic Pain Symptom Inventory.
SECONDARY OBJECTIVES:
I. Evaluate the impact of acupuncture based on neurological assessment, quantitative sensory tests and nerve conduction tests.
II. Evaluate the improvement observed when treating patients for peripheral neuropathy (post-chemotherapy) with acupuncture based on the same metrics.
III. To correlate objective measures of neuropathy (nerve conduction, quantitative sensory tests, neuropathy composite score, and blood cytokine levels) with the subjective questionnaire/quality of life measures.
OUTLINE:
Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive paclitaxel every 2 weeks for 4 courses as standard of care. Patients undergo acupuncture therapy comprising 2 30-minute sessions a week for 4 weeks during courses 3 and 4.
ARM II: Patients receive paclitaxel every 2 weeks for 4 courses as standard of care. Patients then undergo acupuncture therapy comprising 2 30-minute sessions a week for 4 weeks.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm I
Patients receive paclitaxel as standard of care every 2 weeks for 4 courses. Patients undergo acupuncture therapy comprising 2 30-minute sessions a week for 4 weeks during courses 3 and 4.
acupuncture therapy
acupuncture therapy
questionnaire administration
Ancillary study
management of therapy complications
To be determined by the treating physician
Arm II
Patients receive paclitaxel as standard of care every 2 weeks for 4 courses. Patients then undergo acupuncture therapy comprising 2 30-minute sessions a week for 4 weeks.
acupuncture therapy
acupuncture therapy
questionnaire administration
Ancillary study
management of therapy complications
To be determined by the treating physician
Interventions
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acupuncture therapy
acupuncture therapy
questionnaire administration
Ancillary study
management of therapy complications
To be determined by the treating physician
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Performance ECOG 0-2 (Karnofsky Performance Status \>= 60%)
* Life expectancy of greater than 6 months
* Ability to understand and the willingness to sign a written informed consent document
Exclusion
* Patients with radiologically confirmed stage IV breast cancer
* Patients who had acupuncture in the previous 8 weeks
* Change in use of any of the following drugs in the prior 4 weeks: opiates, antidepressants, or anxiolytics ("change" is defined as initiation or cessation of treatment, or change in prescribed dose or regimen)
* Patients with needle phobia
* Patients who experienced any peripheral neuropathy prior to chemotherapy
* Patients who have the potential for serious bleeding due to inherited diseases such as hemophilia
* Patients with diabetes
18 Years
ALL
No
Sponsors
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City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Harry Openshaw
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope
Duarte, California, United States
City of Hope Medical Group Inc
Pasadena, California, United States
Countries
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Other Identifiers
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NCI-2010-00103
Identifier Type: -
Identifier Source: secondary_id
09109
Identifier Type: -
Identifier Source: org_study_id