Acupuncture in Treating Nerve Pain in Patients With Stage I, Stage II, or Stage III Breast Cancer Who Are Receiving Paclitaxel
Study Details
Study Description
Brief Summary
RATIONALE: Acupuncture may help relieve nerve pain caused by chemotherapy.
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
PRIMARY OBJECTIVE:
- 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:
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Evaluate the impact of acupuncture based on neurological assessment, quantitative sensory tests and nerve conduction tests.
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Evaluate the improvement observed when treating patients for peripheral neuropathy (post-chemotherapy) with acupuncture based on the same metrics.
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Other: acupuncture therapy
acupuncture therapy
Other Names:
Other: questionnaire administration
Ancillary study
Other: management of therapy complications
To be determined by the treating physician
Other Names:
|
| Experimental: 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. |
Other: acupuncture therapy
acupuncture therapy
Other Names:
Other: questionnaire administration
Ancillary study
Other: management of therapy complications
To be determined by the treating physician
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change in the Neuropathic Pain Symptom Inventory Scores [At the end of 4 courses of chemotherapy]
Secondary Outcome Measures
- Percentage of patients requiring a dose reduction or additional neuropathy distress related pharmacologic management [Eight weeks after study enrollment]
- Impact of assigning patients the worst score when dose reducing/or prescribing additional treatment [Eight weeks after study enrollment]
- Observed improvement in patients following treatment with acupuncture as to compared to those no longer receiving acupuncture [Eight weeks after study enrollment]
- Comparison of changes in neurological assessment of patients [At the end of therapy and 1 month after the end of therapy]
- Correlation between nerve inventory questionnaires and quantitative nerve tests [Eight weeks after study enrollment]
Eligibility Criteria
Criteria
Inclusion
-
Patients must have a history of histologically or cytologically confirmed stage I, II, or III breast cancer that have received 2 cycles of paclitaxel, and expected to receive paclitaxel for two more cycles, and are experiencing grade 1 peripheral neuropathy (CTCAE criteria)
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Performance ECOG 0-2 (Karnofsky Performance Status >= 60%)
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Life expectancy of greater than 6 months
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Ability to understand and the willingness to sign a written informed consent document
Exclusion
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Patients with radiologically confirmed stage IV breast cancer
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Patients who had acupuncture in the previous 8 weeks
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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)
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Patients with needle phobia
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Patients who experienced any peripheral neuropathy prior to chemotherapy
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Patients who have the potential for serious bleeding due to inherited diseases such as hemophilia
-
Patients with diabetes
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | City of Hope | Duarte | California | United States | 91010 |
| 2 | City of Hope Medical Group Inc | Pasadena | California | United States | 91105 |
Sponsors and Collaborators
- City of Hope Medical Center
Investigators
- Principal Investigator: Harry Openshaw, City of Hope Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 09109
- NCI-2010-00103