A Pilot Study Investigating the Feasibility of Using Acupuncture for the Treatment of Taxane-Induced Peripheral Neuropathy
18 Years
N/A
Both
Breast Cancer, Stage I Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer
Trial Information
A Pilot Study Investigating the Feasibility of Using Acupuncture for the Treatment of Taxane-Induced Peripheral Neuropathy
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. 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. Patients then undergo
acupuncture therapy comprising 2 30-minute sessions a week for 4 weeks.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Change in the Neuropathic Pain Symptom Inventory Scores
Outcome Time Frame:
At the end of 4 courses of chemotherapy
Safety Issue:
No
Principal Investigator
Harry Openshaw
Investigator Role:
Principal Investigator
Investigator Affiliation:
Beckman Research Institute
Authority:
United States: Institutional Review Board
Study ID:
09109
NCT ID:
NCT01050075
Start Date:
January 2010
Completion Date:
May 2012
Related Keywords:
- Breast Cancer
- Stage I Breast Cancer
- Stage II Breast Cancer
- Stage IIIA Breast Cancer
- Stage IIIB Breast Cancer
- Stage IIIC Breast Cancer
- male breast cancer
- neurotoxicity
- recurrent breast cancer
- Breast Neoplasms
- Peripheral Nervous System Diseases
Name | Location |
|---|---|
| City of Hope | Duarte, California 91010 |
| City of Hope Medical Group Inc | Pasadena, California 91105 |
