A Pilot Study of Acupuncture for Chemotherapy-induced Peripheral Neuropathy in Breast Cancer Patients

Status: Recruiting
Phase: N/A
Diagnosis: Breast: Early Stage Disease
NCT ID: NCT02129686 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 14-067

 

This study is being done to evaluate the potential benefits of using acupuncture to reduce symptoms of tingling, burning, numbness and pain in the hands and feet of women with peripheral neuropathy after completion of chemotherapy for breast cancer.

 

Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital

Overall PI:
Weidong Lu, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Breast Cancer Nursing Team, 617-632-3478

Eligibility Criteria

Inclusion Criteria: - History of histologically or cytologically proven breast cancer at stage I, II and III, without evidence of distant metastasis; - Completed adjuvant taxane-based chemotherapy as single agents or in combination with platins or HER-2 directed therapy - Reporting grade 1 or greater of the following symptoms persistently for more than 2 weeks: neuropathic pain, allodynia, areflexia, dysesthesia, paresthesia, hyperesthesia, hypoesthesia or glove and stocking syndrome as defined by Common Terminology Criteria for Adverse Events (CTCAE v. 4.03) (Table 1 and the screening checklist); - Patients who are currently on stable prescription medications or dietary supplements for CIPN and still symptomatic as defined above will be allowed to participate in the study. Related medications are: gabapentin, pregabalin, nortriptyline, amitriptyline, duloxetine, venlafaxine; lidocaine, opioid tramadol and other narcotics; NSAIDs; glutamine, glutathione, vitamin E and vitamin B12; - Age ≥ 18 years; - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; - Adequate hematological function: neutrophil count >1.0 x109/L, platelet count >50x109/L; - Signed informed consent. Exclusion Criteria: - Patients with any of the following criteria will not be eligible for the study: - Unstable cardiac disease or myocardial infarction within 6 months prior to study entry; - Wearing a pacemaker or implantable cardioverter-defibrillator; uncontrolled seizure disorder; - History of pre-existing peripheral neuropathy prior to chemotherapy, including alcoholism, vitamin B deficiency, diabetes, HIV, congenital neuropathy, toxic neuropathy; - Peripheral neuropathy caused by tumor infiltration or compression of spinal nerves or surgical trauma; - Pregnancy or potential pregnancy and nursing; - Active clinically significant uncontrolled infection; - Prior use of acupuncture for CIPN within 6 months prior to study entry; - Patients with uncontrolled major psychiatric disorders, such as major depression or psychosis, will not be eligible for this trial. Patients with a history of depression or anxiety who are stable on or off psychiatric medications will be eligible.
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