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IRCT20190615043900N1 IRCT 2019-06-29 Beijing University of Chinese Medicine Effectiveness of acupuncture in treatment of chemotherapy induced peripheral neuropathy Effectiveness of acupuncture treatment on chemotherapy induced peripheral neuropathy: a pilot randomized controlled trial 2017-06-22 anticipated 40 Complete https://irct.ir/trial/40216 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible participants will be randomized in a ratio of 1:1 to either the acupuncture group or control group. A block randomization list will be created by the ‘blockrand’ package in R software (version 3.3.3), based on n=40 participants and two treatments. The allocation sequence will be concealed from the researchers in sealed, opaque and sequentially numbered envelopes. After the researcher has assessed eligibility, obtained the participant’s consent, and completed all baseline evaluations of the participants, corresponding envelopes will be opened and treatment allocation will be revealed, Blinding description: In acupuncture research, it is not possible to blind the practitioner, and in this study participants are also aware of the type of treatment because one group receive acupuncture and the other group receive pharmacological medication, and it is not feasible to blind participants. But treatment and evaluation will be performed independently. Subjective and objective evaluations and statistical analysis will be performed by blinded specialists, who are not aware of the allocation of participants. N/A Chemotherapy-induced Peripheral Neuropathy. Intervention 1: Intervention group: Acupuncture treatment will be implemented three times per week for four weeks. According to the literature reviews and clinical experiences of a responsible researcher, two groups of points will be used including local points and general points: Qihai (CV 6), Baihui (GV 20), Bilateral Zusanli (ST 36), Sanyinjiao (SP 6), Hegu (LI 4), Quchi (LI 11), Taichong (LR 3) as general points, and bilateral Bafeng (EX-LE 10) and Baxie (EX-UE 9) as local points. Patients with chemotherapy induced peripheral neuropathy (CIPN) symptoms in the lower extremities will be treated with only Bafeng, while patients with CIPN symptoms in the upper extremities will be treated with only Baxie. Patients with CIPN symptoms in both the upper and lower extremities will be treated with a combination of these two points. Additional individualized points will be used, if needed, according to patient symptoms, including Tianshu (ST 25), Waiguan (SJ 5) and Zhaohai (KI 6) for constipation, Neiguan (PC 6) and Zhongwan (CV 12) for vomiting, and Sishencong (EX-HN1) and Shenmen (HE 7) for insomnia. When applying general points, a reinforcing technique will be used at Qihai (CV 6), Zusanli (ST 36), Sanyinjiao (SP 6), and Baihui (GV 20), while a reducing technique will be applied at Hegu (LI 4) and Quchi (LI 11), and an even technique at Taichong (LR 3). For local points, only a reducing technique will be used. After using alcohol for local skin sterilization, disposable sterilized filiform needles (0.25×0.40 mm; Zhongyan Taihe, Beijing Zhongyan Taihe Medical Instruments center, Beijing, China) will be inserted perpendicularly at the depth of 10-15 mm in general points and 5-7 mm in local points, with proper needling manipulation to induce ‘de qi’ (the arrival of qi). After achieving de qi, the needles will be retained for 20 minutes. Intervention 2: Control group: In this group, the treatment consist of one tablet of vitamin B1 300 mg (Jalinous and GNC pharmaceutical companies) and three capsules of gabapentin 300 mg (Abidi and Jiangsu Enhua pharmaceutical companies) per day for four weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Somayeh Iravani
School of Acupuncture and Moxibustion, Beijing University of Chinese Medicine, No.11 North 3rd Ring East Road, Chaoyang Ditrict, Beijing 100029, China
Beijing China 100029 +86 10 5391 2012 iravani_somayeh@bucm.edu.cn Beijing University of Chinese Medicine scientific Amir Hooman Kazemi Motlagh
No.27, Persian Medicine School, North Sarparast st, West Taleghani St, Felestin Square
Tehran Iran (Islamic Republic of) 1417614418 +98 21 2298 8548 hooman_k@tums.ac.ir Tehran University of Medical Sciences China Iran (Islamic Republic of) Patients with age between 18 and 70 years Who have received neurotoxic chemotherapy (at least one complete course) Have experienced symptoms of chemotherapy-induced peripheral neuropathy for more than three months Have scores ≥ 4 on 10 on the Numerical Rating Scale (NRS) Accept and sign an informed consent form Patients were also not to use medications such as Tricyclic antidepressants (TCA), calcium channel blockers, and membrane stabilizing drugs for the prevention or treatment of the neuropathy for at least one month before enrollment 18 years 70 years Both History of disease that causes neuropathy, such as diabetes, multiple sclerosis, HIV, and Parkinson The presence of peripheral neuropathy or history of peripheral neuropathy due to any cause excluding chemotherapy Alcohol abuse Pregnancy Psychological disease Severe dysfunction of the heart, kidneys, or liver G62.0 Drug-induced polyneuropathy Treatment - Other Treatment - Drugs Intervention group: Acupuncture treatment will be implemented three times per week for four weeks. According to the literature reviews and clinical experiences of a responsible researcher, two groups of points will be used including local points and general points: Qihai (CV 6), Baihui (GV 20), Bilateral Zusanli (ST 36), Sanyinjiao (SP 6), Hegu (LI 4), Quchi (LI 11), Taichong (LR 3) as general points, and bilateral Bafeng (EX-LE 10) and Baxie (EX-UE 9) as local points. Patients with chemotherapy induced peripheral neuropathy (CIPN) symptoms in the lower extremities will be treated with only Bafeng, while patients with CIPN symptoms in the upper extremities will be treated with only Baxie. Patients with CIPN symptoms in both the upper and lower extremities will be treated with a combination of these two points. Additional individualized points will be used, if needed, according to patient symptoms, including Tianshu (ST 25), Waiguan (SJ 5) and Zhaohai (KI 6) for constipation, Neiguan (PC 6) and Zhongwan (CV 12) for vomiting, and Sishencong (EX-HN1) and Shenmen (HE 7) for insomnia. When applying general points, a reinforcing technique will be used at Qihai (CV 6), Zusanli (ST 36), Sanyinjiao (SP 6), and Baihui (GV 20), while a reducing technique will be applied at Hegu (LI 4) and Quchi (LI 11), and an even technique at Taichong (LR 3). For local points, only a reducing technique will be used. After using alcohol for local skin sterilization, disposable sterilized filiform needles (0.25×0.40 mm; Zhongyan Taihe, Beijing Zhongyan Taihe Medical Instruments center, Beijing, China) will be inserted perpendicularly at the depth of 10-15 mm in general points and 5-7 mm in local points, with proper needling manipulation to induce ‘de qi’ (the arrival of qi). After achieving de qi, the needles will be retained for 20 minutes. Control group: In this group, the treatment consist of one tablet of vitamin B1 300 mg (Jalinous and GNC pharmaceutical companies) and three capsules of gabapentin 300 mg (Abidi and Jiangsu Enhua pharmaceutical companies) per day for four weeks. Chemotherapy induced peripheral neuropathy symptom severity. Timepoint: Befor treatment, 2 and 4 weeks after starting treatment, as well as 4 weeks after the end of treatment (after 8 weeks). Method of measurement: Chemotherapy induced peripheral neuropathy symptom severity will be assessed by asking patients to rate their average neuropathic symptoms, such as tingling, numbness and pain, on an 11-point scale (Numerical Rating Scale) over the course of a particular day. Grade of sensory neuropathy. Timepoint: Before treatment, 2 and 4 weeks after starting treatment, as well as 4 weeks after the end of treatment (after 8 weeks). Method of measurement: According to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE). Severity of Neuropathy. Timepoint: Before and after treatment. Method of measurement: Nerve Conduction Study (NCS). Patient Overall Satisfaction with Treatment. Timepoint: At the end of treatment and after 4 weeks follow-up (after 8 weeks). Method of measurement: Four-point Likert-type scale. Safety Assessment. Timepoint: After each acupuncture session. Method of measurement: Signs and/or reports of excessive bruising, local persistent pain, and evidence of bleeding. Adverse events. Timepoint: Any time in course of study. Method of measurement: Report by patients and researchers. Tehran University of Medical Sciences Beijing University of Chinese Medicine Tehran University of Medical Sciences Approved 2017-06-20 Ethics Committee Board of Beijing University of Chinese Medicine No.11, 3rd North Ring Road, Chaoyang District Beijing Beijing China Approved 2018-08-20 Ethics committee of Tehran University of Medical Science 6th floor, central building, Qods street, Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)