Clinical Trial of Electroacupuncture Stimulation on Prevention and Treatment of Oxaliplatin Neurotoxicity

Parallel Control Study of Electroacupuncture Stimulation the Acupoints of Yangming Channel on Prevention and Treatment of Oxaliplatin Neurotoxicity During the Peri-chemotherapy Period

The clinical trail of electroacupuncture combined with oxaliplatin regimen on gastrointestinal carcinoma.This trail is randomized controled.Patients are diagnosed gastrointestinal cancer based on pathology or cell biology.They are randomized into 2 groups:both groups receive Oxaliplatin regimen.The treatment group receives electroacupuncture in addition to the chemotherapy.The control group only receive the same chemotherapy with the treatment group.Both group have the same adjuvant therapy.

Study Overview

• Status: Unknown
• Conditions: Gastrointestinal Neoplasms; Neurotoxicity
• Intervention / Treatment: Other: electro-acupuncture

Detailed Description

The clinical trail of electroacupuncture combined with oxaliplatin regimen on gastrointestinal carcinoma.This trail is randomized controled.Patients are diagnosed gastrointestinal cancer based on pathology or cell biology.They are randomized into 2 groups:both groups receive Oxaliplatin regimen.The treatment group receives electroacupuncture in addition to the chemotherapy.The control group only receive the same chemotherapy with the treatment group.Both group have the same adjuvant therapy.Mainly to study about oxaliplatin into electroacupuncture leads to the influence of the peripheral nerve toxicity.Other clinical evaluation includes chemotherapy drug toxicities,quality of life(QOL), etc.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Weiwei Zhang, MM; Phone Number: +8613234062398; Email: 1650579799@qq.com

Study Locations

• China
  • Liaoning
    • Dalian, Liaoning, China, 116011
      • Not yet recruiting
      • The First Affiliated Hospital Of Dalian Medical University
      • Contact: Weiwei Zhang, MM; Phone Number: +8613234062398; Email: 1650579799@qq.com
      • Contact: Xiaonan Cu, MD,PhD; Phone Number: +8618098876725; Email: cxn23@sina.com
    • Dalian, Liaoning, China, 116011
      • Recruiting
      • Oncology Department，The First Affiliated Hospital of Dalian Medical University
      • Contact: Weiwei Zhang, MM; Phone Number: +8613234062398; Email: 1650579799@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age:18-80 ;
2. male and female ;
3. signed the informed consent form;
4. Eastern Cooperative oncology Group(ECOG)O-2,life expectancy more than 3 months;
5. Indication for Chemotherapy,no contraindication;
6. First time chemotherapy or at least 6 months after last chemotherapy and radiotherapy;
7. At least 8 weeks after last biotherapy;
8. Surgery:had not received transplantation surgery,at least 2 weeks after last major surgery.

Exclusion Criteria:

1. Chemotherapy is contraindicated;
2. Having the primary disease can cause the neuropathy;
3. A history of other malignant tumor in recent 5 years;
4. Less than 6 months after last chemotherapy or radiotherapy;
5. Less than 8 weeks after last biotherapy;
6. Being afraid of acupuncture seriously;
7. Had received transplantation surgery,less than 2 weeks after last major surgery;
8. Other researchers think is not suitable for this clinical trail.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: electroacupuncture group; The experimental group adopted chemotherapy combined with electro-acupuncture stimulated related acupoints for 3 days running.	Other: electro-acupuncture; Electroacupuncture was administrated immediately after completion of oxaliplatin infusion,once a day for 3 days,30 minutes each time.
No Intervention: control group; The control group received chemotherapy only(same as the experimental group),but no electroacupuncture treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Levi sensory nerve toxicity classification standard	Scoring scale	every cycle of chemotherapy (measure 3 cycles, each cycle is 21 days), up to 3 months]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The quality of life questionnaire(QLQ)-C30	Scoring scale	every cycle of chemotherapy (measure 3 cycles, each cycle is 21 days), up to 3 months]

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
National Cancer Institute(NCI)Common Toxicity Criteria	Blood and Scoring scale	every cycle of chemotherapy (measure 3 cycles, each cycle is 21 days), up to 3 months]

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Dalian Medical University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Anticipated): March 1, 2018
• Study Completion (Anticipated): May 1, 2018

Study Registration Dates

• First Submitted: September 27, 2017
• First Submitted That Met QC Criteria: October 31, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): November 6, 2017
• Last Update Submitted That Met QC Criteria: October 31, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Digestive System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Diseases; Poisoning; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neurotoxicity Syndromes
• Other Study ID Numbers: YJ-KY-2017-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No