Effect of Adding Electroacupuncture to Anti-cancer Therapy-induced Peripheral Neuropathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhongnan Hospital
About this trial
This study is being done to evaluate the potential benefits of using electroacupuncture to reduce the severity of chemotherapy-induced peripheral neuropathy for patients with peripheral neuropathy after chemotherapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years of age or older, of any nationality.
Patients diagnosed with malignant tumor.
Eligible patients will report altered sensations and/or pain and/or other neurological symptoms, with a grade between 2-3 for chemotherapy-induced peripheral neuropathy on the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events-version 5.0 (NCI-CTCAE.v-5.0).
Predicted life expectancy of ≥3 months.
Disqualifiers
History of pre-existing peripheral neuropathy before chemotherapy, including alcoholism, vitamin B deficiency, diabetes, HIV, congenital neuropathy, and toxic neuropathy.
Patients with skin damage, pus or scar at the acupuncture stimulation area.
Patients who are pregnant or breastfeeding.
Significant mental conditions.
Trial design
Design model
Parallel
Treatments tested in this trial
True acupuncture + standard anti chemotherapy-induced peripheral neuropathy treatment
Procedure/SurgeryParticipants will receive a total of 8 treatments over 6 weeks, with twice a week treatments for the first and the forth weeks and weekly treatment for the remaining weeks.The acupuncturists will insert needles into the acupoints and manipulate the needles until"de qi"sensation is achieved and reported by the participants. In the meantime, participants will receive the same standard anti-CIPN treatments.
Sham acupuncture +standard anti chemotherapy-induced peripheral neuropathy treatment
Procedure/SurgeryThe sham acupuncture comprised a core standardized prescription of minimally invasive, shallow needle insertion using thin and short needles at body locations not recognized as true acupuncture points and are deemed to not belong to traditional Chinese meridians and have no therapeutic value. Participants will receive minimal acupuncture treatment without electrical stimulation at the same time as the intervention group. Care was taken to avoid "de qi" sensation. In the meantime, participants will receive the same standard anti-CIPN treatments.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: True acupuncture + standard anti chemotherapy-induced peripheral neuropathy treatmentExperimental treatment 1 intervention
Group B: Sham acupuncture +standard anti chemotherapy-induced peripheral neuropathy treatmentPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Difference of the CIPN grade from baseline to week 6 after baseline
The primary outcome will be the proportion of patients whose CIPN grade improved after the completion of 8 acupuncture treatments sessions.
Time frame
From enrollment to week 6Secondary outcomes
1
Changes in FACT/NTX subscale baseline to 6 weeks
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) is a 38-item self-reported questionnaire: the 27-item general assessment of Quality of Life scale (FACT-G),alongside its 11-item neurotoxicity-specific module. Considering the patient's compliance, the investigators only require the patient to complete the 11-item neurotoxicity-specific module.
Time frame
baseline,week 3, week6Sponsors and contacts
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Source ClinicalTrials.gov