Trial to Study Electro-Acupuncture in Subjects With Chemotherapy-Induced Peripheral Neuropathy (NCT07455409) | Clinical Trial Compass
CompletedNot Applicable
Trial to Study Electro-Acupuncture in Subjects With Chemotherapy-Induced Peripheral Neuropathy
United States20 participantsStarted 2019-08-29
Plain-language summary
This study will determine the feasibility and efficacy of a 10-treatment electro-acupuncture (EA) program in subjects with chemotherapy-induced peripheral neuropathy (CIPN). The Investigators hypothesize that EA will be a feasible and effective therapy for CIPN.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female aged ≥18 years
* Received curative-intent chemotherapy (i.e., paclitaxel, docetaxel, nab-paclitaxel, carboplatin, oxaliplatin, vinorelbine, ixabepilone, or vincristine) ≥3 months prior to the start of EA treatment
* Persistent Grade ≥2 peripheral neuropathy in the fingers or toes according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0
* Eastern Cooperative Oncology Group performance status of ≤2 (see Section 13.3)
* Willing and able to provide written informed consent for the study.
Exclusion Criteria:
* Documented medical history of neuropathy resulting from nerve compression (e.g., carpal tunnel syndrome, radiculopathy, or spinal stenosis)
* Severe coagulopathy or bleeding disorder, per the treating physician's discretion
* Presence of cellulitis or other skin infection or condition that would preclude placement of acupuncture needles into the hands or feet
* Diabetes unless Hgb A1c \<7.5%
* Unstable cardiac disease
* Pacemaker
* Metal plates
* Known psychiatric disorder that would interfere with cooperation with the requirements of the study
* Pregnant
What they're measuring
1
Number of Participants That Complete ≥ 8 EA Treatments of a 10-treatment EA Program