Acupuncture in Treating Nerve Pain in Patients With Stage I, Stage II, or Stage III Breast Cancer Who Are Receiving Paclitaxel

November 2, 2017 updated by: City of Hope Medical Center

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope
      • Pasadena, California, United States, 91105
        • City of Hope Medical Group Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I
Patients receive paclitaxel as standard of care 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.
Other: questionnaire administration
Ancillary study
Other: acupuncture therapy
acupuncture therapy
Other Names:
  • acupuncture
Other: management of therapy complications
To be determined by the treating physician
Other Names:
  • complications of therapy, management of
Experimental: Arm II
Patients receive paclitaxel as standard of care every 2 weeks for 4 courses. Patients then undergo acupuncture therapy comprising 2 30-minute sessions a week for 4 weeks.
Other: questionnaire administration
Ancillary study
Other: acupuncture therapy
acupuncture therapy
Other Names:
  • acupuncture
Other: management of therapy complications
To be determined by the treating physician
Other Names:
  • complications of therapy, management of

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in the Neuropathic Pain Symptom Inventory Scores
Time Frame: At the end of 4 courses of chemotherapy
At the end of 4 courses of chemotherapy

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients requiring a dose reduction or additional neuropathy distress related pharmacologic management
Time Frame: Eight weeks after study enrollment
Eight weeks after study enrollment
Impact of assigning patients the worst score when dose reducing/or prescribing additional treatment
Time Frame: Eight weeks after study enrollment
Eight weeks after study enrollment
Observed improvement in patients following treatment with acupuncture as to compared to those no longer receiving acupuncture
Time Frame: Eight weeks after study enrollment
Eight weeks after study enrollment
Comparison of changes in neurological assessment of patients
Time Frame: At the end of therapy and 1 month after the end of therapy
At the end of therapy and 1 month after the end of therapy
Correlation between nerve inventory questionnaires and quantitative nerve tests
Time Frame: Eight weeks after study enrollment
Eight weeks after study enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Investigators

  • Principal Investigator: Harry Openshaw, City of Hope Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

January 14, 2010

First Submitted That Met QC Criteria

January 14, 2010

First Posted (Estimate)

January 15, 2010

Study Record Updates

Last Update Posted (Actual)

November 6, 2017

Last Update Submitted That Met QC Criteria

November 2, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09109
  • NCI-2010-00103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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