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Effectiveness of acupuncture treatment on chemotherapy induced peripheral neuropathy: a pilot randomized controlled trial

Protocol summary

Study aim
The aim of this study is to evaluate the effectiveness and safety of acupuncture in treatment of chemotherapy-induced peripheral neuropathy.
Design
Parallel, pilot randomized controlled trial with blinded outcome assessment
Settings and conduct
The study will be conducted on 40 patients with diagnosis of chemotherapy induced peripheral neuropathy referred to Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, and Imam Khomeini Hospital affiliated to Tehran University of Medical Science, that will be randomly assigned to acupuncture or vit B1 and gabapentin groups.
Participants/Inclusion and exclusion criteria
Eligible participants are patients with age between 18 and 70 years, who have received neurotoxic chemotherapy, have experienced symptoms of chemotherapy-induced peripheral neuropathy for more than three months, have scores ≥ 4 on 10 on the Numerical Rating Scale. Patients are not to use medication for prevention or treatment of neuropathy for at least one month before enrollment. Exclusion criteria include diabetes, multiple sclerosis, HIV, Parkinson, alcohol abuse, pregnancy, psychological disease, and severe dysfunction of the heart, kidneys or liver.
Intervention groups
Patients in the acupuncture group will be received twelve sessions (over 4 weeks) of acupuncture. Control group will be taken one tablet of vit B1 300 mg (Jalinous and GNC pharmaceutical companies) and three capsules of gabapentin 300 mg (Abidi and Jiangsu Enhua pharmaceutical companies) per day for 4 weeks, after which both groups will be followed up for 4 weeks.
Main outcome variables
Chemotherapy induced peripheral neuropathy symptom severity, grade of sensory neuropathy, severity of neuropathy, patient overall satisfaction with treatment, safety assessment and adverse events.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190615043900N1
Registration date: 2019-06-29, 1398/04/08
Registration timing: retrospective

Last update: 2019-06-29, 1398/04/08
Update count: 0
Registration date
2019-06-29, 1398/04/08
Registrant information
Name
Somayeh Iravani
Name of organization / entity
Beijing University of Chinese Medicine
Country
China
Phone
+86 10 5391 2012
Email address
iravani_somayeh@bucm.edu.cn
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2018-11-22, 1397/09/01
Actual recruitment start date
2017-06-22, 1396/04/01
Actual recruitment end date
2018-11-22, 1397/09/01
Trial completion date
2018-12-22, 1397/10/01
Scientific title
Effectiveness of acupuncture treatment on chemotherapy induced peripheral neuropathy: a pilot randomized controlled trial
Public title
Effectiveness of acupuncture in treatment of chemotherapy induced peripheral neuropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 40
Actual sample size reached: 40
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee Board of Beijing University of Chinese Medicine
Street address
No.11, 3rd North Ring Road, Chaoyang District
City
Beijing
Postal code
100029
Approval date
2017-06-20, 1396/03/30
Ethics committee reference number
2017BZHYLL0317

2

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Science
Street address
6th floor, central building, Qods street, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417614418
Approval date
2018-08-20, 1397/05/29
Ethics committee reference number
IR.TUMS.VCR.REC.1397.362

Health conditions studied

1

Description of health condition studied
Chemotherapy-induced Peripheral Neuropathy
ICD-10 code
G62.0
ICD-10 code description
Drug-induced polyneuropathy

Primary outcomes

1

Description
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.

Secondary outcomes

1

Description
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)

2

Description
Severity of Neuropathy
Timepoint
Before and after treatment
Method of measurement
Nerve Conduction Study (NCS)

3

Description
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

4

Description
Safety Assessment
Timepoint
After each acupuncture session
Method of measurement
Signs and/or reports of excessive bruising, local persistent pain, and evidence of bleeding

5

Description
Adverse events
Timepoint
Any time in course of study
Method of measurement
Report by patients and researchers

Intervention groups

1

Description
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.
Category
Treatment - Other

2

Description
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.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dongzhimen hospital
Full name of responsible person
Somayeh Iravani
Street address
Department of Hematology and Oncology, Dongcheng District
City
Beijing
Postal code
100700
Phone
+86 10 8401 3145
Email
iravani_somayeh@bucm.edu.cn

2

Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Somayeh Iravani
Street address
Keshavarz boulevard, Bagherkhan street
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2291
Email
iravani_somayeh@bucm.edu.cn

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Beijing University of Chinese Medicine
Full name of responsible person
Baixiao Zhao
Street address
No.11, 3rd North Ring Road, Chaoyang District
City
Beijing
Postal code
100029
Phone
+86 10 5391 2012
Email
baixiao100@vip.sina.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Beijing University of Chinese Medicine
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

2

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
6th floor, Vice-Chancellor in Research Affairs-Tehran University of Medical Sciences, central building, Qods street, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417614418
Phone
+98 21 8889 6696
Email
msahrai@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Beijing University of Chinese Medicine
Full name of responsible person
Somayeh Iravani
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Acupuncture-moxibustion and tuina
Street address
School of Acupuncture and Moxibustion, Beijing University of Chinese Medicine, No.11 North 3rd Ring East Road, Chaoyang Ditrict, Beijing 100029, China
City
Beijing
Province
Beijing
Postal code
100029
Phone
+86 10 5391 2012
Fax
Email
iravani_somayeh@bucm.edu.cn

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amir Hooman Kazemi Motlagh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No.27, Persian Medicine School, North Sarparast st, West Taleghani St, Felestin Square
City
Tehran
Province
Tehran
Postal code
1417614418
Phone
+98 21 2298 8548
Fax
Email
hooman_k@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Beijing University of Chinese Medicine
Full name of responsible person
Somayeh Iravani
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Acupuncture-moxibustion and tuina
Street address
School of Acupuncture and Moxibustion, Beijing University of Chinese Medicine, No.11 North 3rd Ring East Road, Chaoyang Ditrict, Beijing 100029, China
City
Beijing
Province
Beijing
Postal code
100029
Phone
+86 10 5391 2012
Fax
Email
iravani_somayeh@bucm.edu.cn

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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