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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2010-00103 |
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Unable to recruit patients in the 6 month extension allowed.
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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.
PRIMARY OBJECTIVE:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | 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. |
|
| Arm II | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acupuncture therapy | Other | acupuncture therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Neuropathic Pain Symptom Inventory Scores | At the end of 4 courses of chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion
Exclusion
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| Name | Affiliation | Role |
|---|---|---|
| Harry Openshaw | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | United States | ||
| City of Hope Medical Group Inc |
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| questionnaire administration | Other | Ancillary study |
|
| management of therapy complications | Other | To be determined by the treating physician |
|
|
| 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 |
| Pasadena |
| California |
| 91105 |
| United States |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D018567 | Breast Neoplasms, Male |
| D020258 | Neurotoxicity Syndromes |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009422 | Nervous System Diseases |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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