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.
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Change in the Neuropathic Pain Symptom Inventory Scores
At the end of 4 courses of chemotherapy
No
Harry Openshaw
Principal Investigator
Beckman Research Institute
United States: Institutional Review Board
09109
NCT01050075
January 2010
May 2012
Name | Location |
---|---|
City of Hope | Duarte, California 91010 |
City of Hope Medical Group Inc | Pasadena, California 91105 |