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


N/A
18 Years
N/A
Not Enrolling
Both
Breast Cancer, Stage I Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer

Thank you

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 HopeDuarte, California  91010
City of Hope Medical Group IncPasadena, California  91105