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

Gastrointestinal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03330964
• Other study ID #: YJ-KY-2017-102
• Status: Recruiting
• Phase: N/A
• First received: September 27, 2017
• Last updated: October 31, 2017
• Start date: September 1, 2017
• Est. completion date: May 2018

Study information

• Verified date: September 2017
• Source: The First Affiliated Hospital of Dalian Medical University
• Contact: Xiaonan Cui, MD,PhD
• Phone: +8618098876725
• Email: cxn23[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Digestive System Neoplasms
• Gastrointestinal Neoplasms
• Neurotoxicity
• Neurotoxicity Syndromes

Intervention

Other:
• electro-acupuncture
Electroacupuncture was administrated immediately after completion of oxaliplatin infusion,once a day for 3 days,30 minutes each time.

Locations

Country	Name	City	State
China	Oncology Department,The First Affiliated Hospital of Dalian Medical University	Dalian	Liaoning
China	The First Affiliated Hospital of Dalian Medical University	Dalian	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Dalian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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]
Primary	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	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]