Clinical trial NCT03330964: Clinical Trial of Electroacupuncture Stimulation on Prevention and Treatment of Oxaliplatin Neurotoxicity
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neurotoxicity
Gastrointestinal Neoplasms
Lead sponsor: The First Affiliated Hospital of Dalian Medical University
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Levi sensory nerve toxicity classification standard
timeFrame: every cycle of chemotherapy (measure 3 cycles, each cycle is 21 days), up to 3 months]
Secondary outcomes:
measure: The quality of life questionnaire(QLQ)-C30
timeFrame: every cycle of chemotherapy (measure 3 cycles, each cycle is 21 days), up to 3 months]
Other outcomes:
measure: National Cancer Institute(NCI)Common Toxicity Criteria
timeFrame: every cycle of chemotherapy (measure 3 cycles, each cycle is 21 days), up to 3 months]
Locations:
city: Dalian
country: China
facility: Oncology Department，The First Affiliated Hospital of Dalian Medical University
state: Liaoning
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian Medical University
state: Liaoning
Study officials:
affiliation: The First Affiliated Hospital of Dalian Medical University
name: Xiaonan Cui, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: