Clinical trial NCT01050075: Acupuncture in Treating Nerve Pain in Patients With Stage I, Stage II, or Stage III Breast Cancer Who Are Receiving Paclitaxel
Official title: A Pilot Study Investigating the Feasibility of Using Acupuncture for the Treatment of Taxane-Induced Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Stage I Breast Cancer
Stage II Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Keywords: male breast cancer
neurotoxicity
recurrent breast cancer
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
First posted: 2010-01-15
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility 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

Primary outcomes:
measure: Change in the Neuropathic Pain Symptom Inventory Scores
timeFrame: At the end of 4 courses of chemotherapy
Secondary outcomes:
measure: Percentage of patients requiring a dose reduction or additional neuropathy distress related pharmacologic management
timeFrame: Eight weeks after study enrollment
measure: Impact of assigning patients the worst score when dose reducing/or prescribing additional treatment
timeFrame: Eight weeks after study enrollment
measure: Observed improvement in patients following treatment with acupuncture as to compared to those no longer receiving acupuncture
timeFrame: Eight weeks after study enrollment
measure: Comparison of changes in neurological assessment of patients
timeFrame: At the end of therapy and 1 month after the end of therapy
measure: Correlation between nerve inventory questionnaires and quantitative nerve tests
timeFrame: Eight weeks after study enrollment
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: Pasadena
country: United States
facility: City of Hope Medical Group Inc
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Harry Openshaw
role: PRINCIPAL_INVESTIGATOR
References: