Clinical Trial of Acupuncture for Chemotherapy-Induced Peripheral Neuropathy

NCT ID: NCT03881748

Last Updated: 2021-12-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-31
• Study Completion Date: 2021-12-31

Brief Summary

The goal of this clinical research study is to learn if one acupuncture treatment approach is more effective than another in helping to relieve chemo-therapy induced neuropathy in cancer patients. If eligible to take part in this study, participants will be randomly assigned to 1 of 2 groups - group 1 participants will receive traditional acupuncture treatments 2 times a week for a total of 20 sessions. Group 2 participants will have acupuncture sessions with electrical stimulation 2 times a week for a total of 20 sessions.

Detailed Description

Peripheral neuropathy is a common problem among cancer patients who have received chemotherapy treatment. Peripheral neuropathy often causes weakness, numbness and pain, usually in the hands and feet. It can also affect other areas of the body. People with peripheral neuropathy generally describe the pain as stabbing, burning or tingling.

Acupuncture is a technique that may treat symptoms by inserting very thin, solid, sterile, stainless steel needles into the skin at specific points. Research has shown that acupuncture can reduce symptoms of pain and nausea by altering pain signaling along nerves. The effect of acupuncture can be enhanced by additional movement of the needles called manual acupuncture, which involves rotating the needle and moving it up and down. Another type of acupuncture is called electro-acupuncture, which involves running a low level electrical current between two needle points. Preliminary studies indicate that acupuncture may also be helpful to treat chemotherapy related neuropathy. This trial will determine the relative effects of both manual acupuncture and electro-acupuncture for treating chronic chemotherapy-induced neuropathy.

Participants will be assigned to one of two groups: 1) manual acupuncture twice a week for 20 treatments or 2) electro-acupuncture twice a week for 20 treatments. Multiple assessments will be performed at baseline and approximately every 2 weeks for a total of 16 weeks while subjects are on study.

Conditions

Peripheral Neuropathy

Keywords

Acupuncture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Manual acupuncture

Insertion of very thin, solid, sterile, stainless steel needles into the skin at specific points.

Group Type: EXPERIMENTAL

Manual acupuncture

Intervention Type: OTHER

Manual acupuncture twice a week for 20 treatments.

Acupuncture will be administered on an outpatient basis in private rooms with participants lying supine. The acupuncturist will disinfect the selected acupuncture points with alcohol and then needle them so that the participant achieves a "de qi" sensation if possible, which is often described as a pressure or achiness feeling. Acupuncture needles will be left in place for approximately 20 minutes.

Electro-acupuncture

Insertion of very thin, solid, sterile, stainless steel needles into the skin at specific points with additional application of weak electrical stimulation

Group Type: EXPERIMENTAL

Electro-acupuncture

Intervention Type: OTHER

Electro-acupuncture twice a week for 20 treatments.

Acupuncture will be administered on an outpatient basis in private rooms with participants lying supine. The acupuncturist will disinfect the selected acupuncture points with alcohol and then needle them so that the participant achieves a "de qi" sensation if possible, which is often described as a pressure or achiness feeling. Acupuncture needles will be left in place for approximately 20 minutes.

Electrical stimulation will be applied to the needles concomitantly and continuously to acupuncture points by placing lead wires on the needles connected to an electro-acupuncture stimulator such as the Model IC-1107. The stimulator will be set on the Dense-Disperse wave setting with low frequency at 2-10 Hz and high frequency at 100-110 Hz. The needles will not be manually stimulated after electrical stimulation is applied.

Interventions

Manual acupuncture

Manual acupuncture twice a week for 20 treatments.

Acupuncture will be administered on an outpatient basis in private rooms with participants lying supine. The acupuncturist will disinfect the selected acupuncture points with alcohol and then needle them so that the participant achieves a "de qi" sensation if possible, which is often described as a pressure or achiness feeling. Acupuncture needles will be left in place for approximately 20 minutes.

Intervention Type: OTHER

Electro-acupuncture

Electro-acupuncture twice a week for 20 treatments.

Acupuncture will be administered on an outpatient basis in private rooms with participants lying supine. The acupuncturist will disinfect the selected acupuncture points with alcohol and then needle them so that the participant achieves a "de qi" sensation if possible, which is often described as a pressure or achiness feeling. Acupuncture needles will be left in place for approximately 20 minutes.

Electrical stimulation will be applied to the needles concomitantly and continuously to acupuncture points by placing lead wires on the needles connected to an electro-acupuncture stimulator such as the Model IC-1107. The stimulator will be set on the Dense-Disperse wave setting with low frequency at 2-10 Hz and high frequency at 100-110 Hz. The needles will not be manually stimulated after electrical stimulation is applied.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Participants must have the ability to understand English, sign a written informed consent document, and be willing to follow protocol requirements.
• History of a diagnosis of cancer, verifiable through documentation in a medical record.
• Participants must have neuropathy ≥1 according to CTCAE v 4.0 scale or a neuropathy score of >3 on a 0-10 scale despite previous treatment, which may include Neurontin, Cymbalta and/or Lyrica.
• The participant's previous chemotherapy treatment must have included a taxane (paclitaxel, nab-paclitaxel, or docetaxel) or platinum (cisplatin, oxaliplatin, or carboplatin) and considered the primary cause of the neuropathy by the medical team.
• More than 6 months since last treatment
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2.
• Willingness to comply with all study interventions of acupuncture and follow-up assessments.

Exclusion Criteria

• 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 bortezomib chemotherapy within the past 6 months.
• Local infection at or near the acupuncture site. (Although acupuncture is a minimally invasive procedure, participants 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 and minerals.
• Known coagulopathy or taking heparin (including low molecular weight heparin) at full anti-coagulation doses (prophylaxis is allowed) or Coumadin at any dose. Participants 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 participants with CNS pathology may respond differently to treatment than the general population.)
• Implanted electrical device such as cardiac pacemaker, insulin pump, or pain pump.
• Mental incapacitation or significant emotional or psychological disorder that, in the opinion of the investigators, precludes study entry. (These participants 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, neuropathy related to HIV, or other medical causes of chronic neuropathy in the baseline assessment including past medical history, any history of diabetes, alcoholism, and vitamin B.
• 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 chemotherapy-induced peripheral neuropathy (CIPN). New medications for the treatment of CIPN are not allowed during the study. Subjects need to be on stable doses of CIPN medications for 4 weeks.
• Grade III lymphedema or lymphedema considered severe by the treating clinician

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Lee, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

CASE4Y18

Identifier Type: -

Identifier Source: org_study_id