Status:
TERMINATED
Acupuncture Chemotherapy-Induced Peripheral Neuropathy (CIPN) IRG
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The goal of this clinical research study is to compare the level of effectiveness for 2 acupuncture treatment schedules for chronic CIPN in breast cancer survivors. Researchers also want to study how ...
Detailed Description
Peripheral neuropathy is one of the most common chemotherapy side effects affecting the nerves. Each year, thousands of patients receive taxane-based chemotherapy and more than 50-60% of these patient...
Eligibility Criteria
Inclusion
- Patients must have the ability to understand English, sign a written informed consent document, and be willing to follow protocol requirements.
- Age \>/= 18 years.
- History of a diagnosis of breast cancer.
- Patients must have neuropathy greater or equal to 2 according to CTCAE v 4.0 scale, clinically evaluated within 30 days of consent, despite previous treatment, which may include Neurontin, Cymbalta and/or Lyrica for at least 30 days. Patients receiving any of these drugs must remain on the same medications throughout the study period; however, adjustments in dosage are allowed. Patients are allowed to stop medications but not replace them with other medications.
- The patient's previous chemotherapy treatment must have included a taxane (paclitaxel, nab-paclitaxel, or docetaxel) and considered the primary cause of the neuropathy by the medical team.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2.
- Ability to complete the 4 or 6 weeks of acupuncture and follow-up assessments.
Exclusion
- Current active treatment with chemotherapy , radiation or surgery in the past 3 months or planned treatment during this study protocol period. Hormonal therapy is allowed.
- Treatment with any neuropathic agent including taxane, platinum, vinca alkaloid, or bortezumab chemotherapy in the past 6 months.
- Local infection at or near the acupuncture site. (Although acupuncture is a minimally invasive procedure, patients will be excluded if there is an indication of infection.)
- Physical deformities that could interfere with accurate acupuncture point location.
- Concurrent use of other alternative medicines such as herbal agents and high dose vitamins.
- Known coagulopathy or taking heparin (including low molecular weight heparin) at full anti-coagulation doses (prophylaxis is allowed) or Coumadin at any dose. Patients on aspirin or non-steroidal anti-inflammatories or other antiplatelet medicines will be allowed to participate.
- Platelets \< 50 H K/UL in the past 30 days.
- White blood cells (WBCs) \< 3.0 K/UL or absolute neutrophil count (ANC) \<1,500 K/UL) in the past 30 days.
- Active central nervous system (CNS) disease. (The action for acupuncture may be associated with central nervous system activity, and patients with CNS pathology may respond differently to treatment than the general population.)
- Cardiac pacemaker.
- Mental incapacitation or significant emotional or psychological disorder that, in the opinion of the investigators, precludes study entry. (These patients may not be able to cooperate with this slightly invasive procedure or with the data collection process.)
- Currently pregnant. (Certain acupuncture applications have been reported to stimulate uterine contractions.)
- History of diabetic neuropathy or neuropathy related to HIV.
- Previous acupuncture treatment for any indication within 30 days of enrollment.
- Planned or actual changes in type of medications that could affect symptoms related to CIPN. New medications for the treatment of CIPN are not allowed during the study. Note: Subjects need to be on stable doses for 4 weeks.
- Grade III lymphedema or lymphedema considered severe by the treating clinician.
Key Trial Info
Start Date :
July 6 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 10 2016
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01815346
Start Date
July 6 2014
End Date
May 10 2016
Last Update
January 12 2018
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030