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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01050075
• Other study ID #: 09109
• Secondary ID: NCI-2010-00103
• Status: Terminated
• Phase: N/A
• First received: January 14, 2010
• Last updated: November 2, 2017
• Start date: January 2010
• Est. completion date: May 2012

Study information

• Verified date: November 2017
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Stage I Breast Cancer
• Stage II Breast Cancer
• Stage IIIA Breast Cancer
• Stage IIIB Breast Cancer
• Stage IIIC Breast Cancer

Intervention

Other:
• acupuncture therapy
acupuncture therapy
• questionnaire administration
Ancillary study
• management of therapy complications
To be determined by the treating physician

Locations

Country	Name	City	State
United States	City of Hope	Duarte	California
United States	City of Hope Medical Group Inc	Pasadena	California

Sponsors (1)

Lead Sponsor	Collaborator
City of Hope Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Neuropathic Pain Symptom Inventory Scores		At the end of 4 courses of chemotherapy
Secondary	Percentage of patients requiring a dose reduction or additional neuropathy distress related pharmacologic management		Eight weeks after study enrollment
Secondary	Impact of assigning patients the worst score when dose reducing/or prescribing additional treatment		Eight weeks after study enrollment
Secondary	Observed improvement in patients following treatment with acupuncture as to compared to those no longer receiving acupuncture		Eight weeks after study enrollment
Secondary	Comparison of changes in neurological assessment of patients		At the end of therapy and 1 month after the end of therapy
Secondary	Correlation between nerve inventory questionnaires and quantitative nerve tests		Eight weeks after study enrollment