Electro-acupuncture for the Prevention of Taxane Induced Myalgias and Neuropathy

Columbia University

Status: Completed

Conditions: Breast Cancer; Neuropathy

Treatments: Device: Sham acupuncture; Device: Electro-acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT01163682

AAAE7054

Details and patient eligibility

About

This study seeks to determine if 12 weeks of weekly electro-acupuncture will prevent or decrease neuropathic pain in breast cancer patients receiving 12 weekly treatments of taxane treatment.

Full description

Chemotherapy induced neuropathy (CIN) is a common and disabling toxicity of cytotoxic chemotherapy. Depending on the drug, it is often irreversible even after the offending agent is removed. The consequence of terminating effective anti-tumor therapy or dose reduction can be catastrophic to the effect of a patient's cancer treatment. Given the morbidity of taxane induced neuropathy, the lack of effective preventative treatment for taxane induce neuropathy and the safety of acupuncture, it is reasonable to test the efficacy of this non pharmacological intervention in woman with Stage I-III breast cancer receiving adjuvant or neo-adjuvant weekly paclitaxel for 12 weeks.

Enrollment: 63 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age>21 years
• History of stage I-III breast cancer
• Patient scheduled to be receiving weekly adjuvant or neo-adjuvant paclitaxel for 12 weeks
• Signed informed consent

Exclusion criteria

• Previous treatment with acupuncture in the last 12 months
• Diabetic Neuropathy or other neurological conditions
• Inflammatory, metabolic or neuropathic arthropathies
• Current narcotic use
• Severe concomitant illnesses
• Severe coagulopathy or bleeding disorder
• Dermatological disease within the acupuncture area
• Have a pacemaker

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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63 participants in 2 patient groups

Electro-acupuncture

Experimental group

Description:

Subjects will receive 45 minute sessions scheduled once a week for 12 weeks with electro-acupuncture.

Treatment:

Device: Electro-acupuncture

Sham acupuncture

Sham Comparator group

Description:

Subjects will receive 45 minute sessions scheduled once a week for 12 weeks with sham acupuncture.

Treatment:

Device: Sham acupuncture