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

This study has been terminated.
(Unable to recruit patients in the 6 month extension allowed.)
Sponsor:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT01050075
First received: January 14, 2010
Last updated: July 13, 2012
Last verified: July 2012

January 14, 2010
July 13, 2012
January 2010
May 2012   (final data collection date for primary outcome measure)
Change in the Neuropathic Pain Symptom Inventory Scores [ Time Frame: At the end of 4 courses of chemotherapy ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01050075 on ClinicalTrials.gov Archive Site
  • Percentage of patients requiring a dose reduction or additional neuropathy distress related pharmacologic management [ Time Frame: Eight weeks after study enrollment ] [ Designated as safety issue: No ]
  • Impact of assigning patients the worst score when dose reducing/or prescribing additional treatment [ Time Frame: Eight weeks after study enrollment ] [ Designated as safety issue: No ]
  • Observed improvement in patients following treatment with acupuncture as to compared to those no longer receiving acupuncture [ Time Frame: Eight weeks after study enrollment ] [ Designated as safety issue: No ]
  • Comparison of changes in neurological assessment of patients [ Time Frame: At the end of therapy and 1 month after the end of therapy ] [ Designated as safety issue: No ]
  • Correlation between nerve inventory questionnaires and quantitative nerve tests [ Time Frame: Eight weeks after study enrollment ] [ Designated as safety issue: No ]
  • Percentage of patients requiring a dose reduction or additional neuropathy distress related pharmacologic management [ Designated as safety issue: No ]
  • Impact of assigning patients the worst score when dose reducing/or prescribing additional treatment [ Designated as safety issue: No ]
  • Observed improvement in patients following treatment with acupuncture as to compared to those no longer receiving acupuncture [ Designated as safety issue: No ]
  • Comparison of changes in neurological assessment of patients [ Time Frame: At the end of therapy and 1 month after the end of therapy ] [ Designated as safety issue: No ]
  • Correlation between nerve inventory questionnaires and quantitative nerve tests [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Acupuncture in Treating Nerve Pain in Patients With Stage I, Stage II, or Stage III Breast Cancer Who Are Receiving Paclitaxel
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.

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
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Breast Cancer
  • Stage I Breast Cancer
  • Stage II Breast Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIC Breast Cancer
  • Procedure: acupuncture therapy
    acupuncture therapy
    Other Name: acupuncture
  • Drug: paclitaxel
    Dosage to be determined by the treating physician
    Other Names:
    • Anzatax
    • Asotax
    • Bristaxol
    • Praxel
    • TAX
    • Taxol
  • Other: questionnaire administration
    Ancillary study
  • Procedure: management of therapy complications
    To be determined by the treating physician
    Other Name: complications of therapy, management of
  • Experimental: 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.
    Interventions:
    • Procedure: acupuncture therapy
    • Drug: paclitaxel
    • Other: questionnaire administration
    • Procedure: management of therapy complications
  • Experimental: 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.
    Interventions:
    • Procedure: acupuncture therapy
    • Drug: paclitaxel
    • Other: questionnaire administration
    • Procedure: management of therapy complications
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
7
May 2012
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01050075
09109, NCI-2010-00103
Yes
City of Hope Medical Center
City of Hope Medical Center
Not Provided
Principal Investigator: Harry Openshaw Beckman Research Institute
City of Hope Medical Center
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP