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A Pilot Study Investigating the Feasibility of Using Acupuncture for the Treatment of Taxane-Induced Peripheral Neuropathy

This study is currently Recruiting

September 2011 By City of Hope Medical Center

First Recieved on January 14, 2010

Last Updated on September 20, 2011

Sponsor: City of Hope Medical Center
Collaborators:
Information provided by: City of Hope Medical Center
Identifier: NCT01050075

Purpose

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.

Study Type: Interventional
Study Design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Eligibility

Ages Eligible for Study:18 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
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

Investigators

  • Investigator: Harry Openshaw - Principal Investigator - Beckman Research Institute

Locations

  • City of Hope

    Duarte, California 91010 United States

  • City of Hope Medical Group Inc

    Pasadena, California 91105 United States

Conditions related to this trial:

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