Breast Cancer, Stage I Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer
Conditions
Keywords
male breast cancer, neurotoxicity, recurrent breast cancer
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.
Detailed description
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.
Interventions
OTHERacupuncture therapy
acupuncture therapy
OTHERquestionnaire administration
Ancillary study
OTHERmanagement of therapy complications
To be determined by the treating physician
Sponsors
City of Hope Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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) * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the Neuropathic Pain Symptom Inventory Scores | At the end of 4 courses of chemotherapy |
Secondary
| Measure | 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 | 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 |
Countries
United States
Outcome results
None listed