NCT01163682

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

Randomized Sham Controlled Trial of Weekly Electro-acupuncture for the Prevention of Taxane Induced Myalgias and Neuropathy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Breast Cancer
• Neuropathy

Interventions

Type	Name	Description
DEVICE	Electro-acupuncture	Subjects will be placed in prone position and acupuncture sites will be cleaned with alcohol preparation. Stainless steel disposable acupuncture needle (diameter 0.25mm) will be inserted into the skin to appropriate depth needed to elicit de qi(approximately 3-4mm). Selected acupuncture points will be attached to2 leads connected to an electro-stimulator that generates 2 Hz of mixed pulsatile intervals for a total of 30 minutes. The acupuncturist will return two times during the treatment at 10 and 20 minutes with needles in situ to check on the patients and needles. Needles not attached to the electro-stimulator will be manipulated manually to elicit de qi one time during the treatment.
DEVICE	Sham acupuncture	Will be utilizing a sham control that consists of collapsible acupuncture needle so that there is no penetration of skin. The sham needles will be place on 4 non specific body points. The electro-stimulator will be attached to the needles for 30 minutes but will not be turned on. The acupuncturist will return two times during the treatment at 10 and 20 minutes to check on the patient. The acupuncturist will touch the collapsible acupuncture needs to simulate the manipulation of the needles.

Timeline

• Start date: 2010-12-01
• Primary completion: 2015-12-01
• Completion: 2017-05-01
• First posted: 2010-07-16
• Last updated: 2023-09-21
• Results posted: 2023-09-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study