Clinical trial NCT04739631: Efficacy of Acupuncture on Chemotherapy-Induced Peripheral Neuropathy
Official title: Efficacy of Acupuncture on Chemotherapy-Induced Peripheral Neuropathy (CIPN): A Phase III, Randomized, Sham-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Keywords: acupuncture
chemotherapy-induced peripheral neuropathy
neuropathic pain
von-Frey monofilament test
taxane
platinum
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
Collaborators: name: China Medical University Hospital
First posted: 2021-02-04
Enrollment: 94
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the neurological efficacy of acupuncture in patients with cancer who experienced peripheral neuropathy, which is induced by chemotherapy.

Detailed description: Background: Chemotherapy may lead to peripheral neuropathy up to 40% in cancer survivors, especially in some types of patients with cancer. The effect of acupuncture, an ancient Chinese medicine technique, was recognized by the World Health Organization (WHO) in the treatment of several diseases. The postulated mechanisms associated with acupuncture in analgesia or neurogenesis are still under investigation. Considering a moderate recommendation for duloxetine in the treatment of chemotherapy-induced peripheral neuropathy (CIPN) based on based on neuropathic pain, and a few treatment options with evidence for CIPN, acupuncture might be another option. Nowadays, only small scale pilot studies provided initial proof of acupuncture in CIPN, particularly in decreasing neuropathic pain and improving neurotoxicity, the study aims to determine the beneficial effects of acupuncture on CIPN with a large-scale, multicenter, randomized sham-controlled clinical trial. Furthermore, the aim of the study will provide evidence for the clinical therapeutic guideline of CIPN in the future.

Eligibility criteria: Inclusion criteria:

The study will enroll patients with a symptom of peripheral neuropathy, including paresthesia, numbness, glove-and-stocking sensory loss distribution or pain in four limbs, and meet the following inclusion criteria:

1. All adult cancer patients (Age≧20-year-old) who received chemotherapy regimens, including adjuvant and neoadjuvant therapy
2. Stage I-III cancer patients
3. Completed chemotherapy regimens more than3 months, including Taxanes (paclitaxel or docetaxel), platinum (cisplatin, oxaliplatin, carboplatin)
4. Baseline von Frey Monofilament test (Target force at hand) ≧ 0.07gms
5. Baseline von Frey Monofilament test (Target force at foot) ≧ 0.4gms
6. Eastern Cooperative Oncology Group (ECOG) performance status ≦3
7. Grading of peripheral sensory neuropathy in National Cancer Institute- common terminology criteria for adverse events,v5.0 (NCI-CTCAE5) ≧1
8. Patients were restricted acupuncture treatment for one month before recruitment
9. Written patient informed consent

Exclusion criteria:

Participants with any of the following conditions will be excluded:

1. Uncontrolled Diabetic Mellitus, HbA1c≧7% is inappropriate\[19\].
2. Diabetic neuropathy diagnosed before receiving chemotherapy
3. Neuropathy from any type of nerve compression (e.g., carpal/tarsal tunnel syndrome, radiculopathy, spinal stenosis, brachial plexopathy)
4. Concomitant with duloxetine, or another analgesia, including Pregabalin, Venlafaxine, Minocycline, Topical gel, Oxycodone, Naloxone, Cannabinoids, and Angiotensin II type 2 receptor antagonist
5. Severe hemorrhagic coagulopathy or bleeding tendency
6. Unstable cardiovascular disease
7. Severe skin lesions around the treatment sites The researchers will exclude any participants considered to be inappropriate for the study.

Primary outcomes:
measure: FACT-Neurotoxicity subscale(NtxS)
timeFrame: It will be assessed before the first intervention in the first week, after the 12th intervention in the 4th week , after the 20th intervention in the 8th week, and the follow-up assessment in the end of the 12th week. Each intervention is one day.
Secondary outcomes:
measure: The change of BPI-SF
timeFrame: It will be assessed before the first intervention in the first week, after the 12th intervention in the 4th week , after the 20th intervention in the 8th week, and the follow-up assessment in the end of the 12th week. Each intervention is one day.
measure: The quantitative sensation of touch detection
timeFrame: It will be assessed before the first intervention in the first week, after the 20th intervention in the 8th week, and the follow-up assessment in the end of the 12th week. Each intervention is one day.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
References: