Clinical Trial of Acupuncture for Chemotherapy-Induced Peripheral Neuropathy

NCT03881748 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-12-01

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Case Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Richard Lee, MD · University Hospitals Cleveland Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-31
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03881748 on ClinicalTrials.gov