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

NCT03048591 | Unknown

• 1 other identifier: E2016014A
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Chemotherapy-induced Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• Quality of life questionnaire to assess chemotherapy-induced peripheral neuropathy (QLQ-CIPN20)

  6 weeks

Secondary Outcomes (1)

• Functional Assessment of Cancer Treatment - General scale（FACT-G）

  6 weeks

Study Arms (2)

Electroacupuncture group

EXPERIMENTAL

Device: electroacupuncture

control group

NO INTERVENTION

Interventions

electroacupuncture DEVICE

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

Electroacupuncture group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The histopathological and / or cellular pathology results prove malignancy of the tumor and the patient has received chemotherapy treatment before.
• weeks after the completion of chemotherapy, the limbs are still feeling abnormal and the symptoms fulfill World Health Organization (WHO) grade 2 or more.
• 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.
• Gender unrestricted, aged between 18 to 80 years old.
• Voluntary participation in the study, will to sign informed consent, willing to comply with randomized grouping, will to follow-up.

You may not qualify if:

• 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.
• Patients who are being treated with other drugs that may lead to neurotoxicity .
• Patients with blood coagulation disorder.
• Pregnancy and lactating women.
• Patients with infection, scarring or defects near the acupoint sites.
• 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.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

MeSH Terms

Interventions

Electroacupuncture

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Bin Wang

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bin Wang

CONTACT

+8613820156627; wbin8888@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2017
• First Posted: February 9, 2017
• Study Start: February 10, 2018
• Primary Completion: September 1, 2018
• Study Completion: November 1, 2018
• Last Updated: February 12, 2018

Record last verified: 2017-02