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
1 other identifier
interventional
120
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2017
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2017
CompletedFirst Submitted
Initial submission to the registry
September 27, 2017
CompletedFirst Posted
Study publicly available on registry
November 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedNovember 6, 2017
September 1, 2017
6 months
September 27, 2017
October 31, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
The quality of life questionnaire(QLQ)-C30
every cycle of chemotherapy (measure 3 cycles, each cycle is 21 days), up to 3 months]
Other Outcomes (1)
National Cancer Institute(NCI)Common Toxicity Criteria
every cycle of chemotherapy (measure 3 cycles, each cycle is 21 days), up to 3 months]
Study Arms (2)
electroacupuncture group
EXPERIMENTALThe experimental group adopted chemotherapy combined with electro-acupuncture stimulated related acupoints for 3 days running.
control group
NO INTERVENTIONThe control group received chemotherapy only(same as the experimental group),but no electroacupuncture treatment.
Interventions
Electroacupuncture was administrated immediately after completion of oxaliplatin infusion,once a day for 3 days,30 minutes each time.
Eligibility Criteria
You may qualify if:
- Age:18-80 ;
- male and female ;
- signed the informed consent form;
- Eastern Cooperative oncology Group(ECOG)O-2,life expectancy more than 3 months;
- Indication for Chemotherapy,no contraindication;
- First time chemotherapy or at least 6 months after last chemotherapy and radiotherapy;
- At least 8 weeks after last biotherapy;
- Surgery:had not received transplantation surgery,at least 2 weeks after last major surgery.
You may not qualify if:
- Chemotherapy is contraindicated;
- Having the primary disease can cause the neuropathy;
- A history of other malignant tumor in recent 5 years;
- Less than 6 months after last chemotherapy or radiotherapy;
- Less than 8 weeks after last biotherapy;
- Being afraid of acupuncture seriously;
- Had received transplantation surgery,less than 2 weeks after last major surgery;
- Other researchers think is not suitable for this clinical trail.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Oncology Department，The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116011, China
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116011, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaonan Cui, MD,PhD
The First Affiliated Hospital of Dalian Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2017
First Posted
November 6, 2017
Study Start
September 1, 2017
Primary Completion
March 1, 2018
Study Completion
May 1, 2018
Last Updated
November 6, 2017
Record last verified: 2017-09