NCT03881748

Clinical Trial of Acupuncture for Chemotherapy-Induced Peripheral Neuropathy

A Randomized Phase II Pilot Clinical Trial of Acupuncture for Chemotherapy-Induced Peripheral Neuropathy

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	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.
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.

Timeline

• Start date: 2021-10-01
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2019-03-19
• Last updated: 2021-12-01

Locations

1 site across 1 country: United States