The Exploratory Study of Electroacupuncture in the Treatment of Peripheral Neuropathy Induced by Platinum Based Chemotherapy Drugs

Chemotherapy-induced Peripheral Neuropathy Clinical Trial

Official title:

The Exploratory Study of Electroacupuncture in the Treatment of Peripheral Neuropathy Induced by Platinum Based Chemotherapy Drugs

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03048591
• Other study ID #: E2016014A
• Status: Not yet recruiting
• Phase: N/A
• First received: February 7, 2017
• Last updated: February 8, 2018
• Start date: February 10, 2018
• Est. completion date: November 1, 2018

Study information

• Verified date: February 2017
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Bin Wang
• Phone: +8613820156627
• Email: wbin8888[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Through the research to confirm the effectiveness and safety of using electroacupuncture in the treatment of chemotherapy-induced peripheral neuropathy.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: November 1, 2018
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. The histopathological and / or cellular pathology results prove malignancy of the tumor and the patient has received chemotherapy treatment before.

2. 15weeks after the completion of chemotherapy, the limbs are still feeling abnormal and the symptoms fulfill World Health Organization (WHO) grade 2 or more.

3. zubrod - Eastern Cooperative Oncology Group-WHO (ZPS) grade 0-2, cardiac function, liver function and renal function are not significantly abnormal, the survival period of the patient is expected to be more than 6 months.

4. Gender unrestricted, aged between 18 to 80 years old.

5. Voluntary participation in the study, will to sign informed consent, willing to comply with randomized grouping, will to follow-up.

Exclusion Criteria:

1. Patients who suffer from peripheral neuropathy due to infection, radiotherapy, HIV, chronic alcoholism, hypothyroidism, diabetes, paraneoplastic syndrome or other diseases; or are suffering from nervous system diseases.

2. Patients who are being treated with other drugs that may lead to neurotoxicity .

3. Patients with blood coagulation disorder.

4. Pregnancy and lactating women.

5. Patients with infection, scarring or defects near the acupoint sites.

6. Received intervention for the prevention and treatment of peripheral neuropathy 2 weeks before screening or has received traditional Chinese medicine (acupuncture, moxibustion, cupping, Chinese medicine therapy one month before.

Related Conditions & MeSH terms

• Chemotherapy-induced Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

Device:
• electroacupuncture
Acupoint selection: Bilateral Hegu (LI4), Qu-chi (LI1) of upper limbs and bilateral Zusanli (ST36) ,Taichung (LR3)of lower limbs.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life questionnaire to assess chemotherapy-induced peripheral neuropathy (QLQ-CIPN20)		6 weeks
Secondary	Functional Assessment of Cancer Treatment - General scale(FACT-G)		6 weeks