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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
History of Changes
  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.


Condition Intervention
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
Drug: paclitaxel
Other: questionnaire administration
Procedure: management of therapy complications

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Pilot Study Investigating the Feasibility of Using Acupuncture for the Treatment of Taxane-Induced Peripheral Neuropathy

Resource links provided by NLM:

Drug Information available for: Paclitaxel
U.S. FDA Resources

Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • Change in the Neuropathic Pain Symptom Inventory Scores [ Time Frame: At the end of 4 courses of chemotherapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 7
Study Start Date: January 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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 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.
 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

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. 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01050075

Locations
United States, California
City of Hope
Duarte, California, United States, 91010
City of Hope Medical Group Inc
Pasadena, California, United States, 91105
Sponsors and Collaborators
City of Hope Medical Center
Investigators
Principal Investigator: Harry Openshaw Beckman Research Institute
  More Information

No publications provided

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT01050075     History of Changes
Other Study ID Numbers: 09109, NCI-2010-00103
Study First Received: January 14, 2010
Last Updated: July 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by City of Hope Medical Center:
male breast cancer
neurotoxicity
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Peripheral Nervous System Diseases
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neuromuscular Diseases
Nervous System Diseases
Paclitaxel
 Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013