The Comparative Study on the Efficacy and Safety of Single Acupoint and Matching Acupoints

NCT03061396 | Unknown

• 1 other identifier: 2014CB543201-03
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to clarify whether the matching acupoints are more effective than a single point by electro-acupuncture in the management of chemotherapy-induced nausea and vomiting.

Conditions

Electro-acupuncture; Chemotherapy-induced Nausea and Vomiting

Outcome Measures

Primary Outcomes (3)

• Complete Control rates of Nausea and Vomiting

  There is no emetic episodes, no rescue therapy, and no significant nausea from first day of antiemetic therapy to 5th day.

  6weeks

• Complete Response rates of Vomiting

  There is no emetic episodes and no rescue therapy on first day of antiemetic therapy and second day to 5th day.

  6weeks

• Nausea and Vomiting visual analogic scale (VAS)

  6weeks

Secondary Outcomes (5)

• Tcm Gastro-intestinal evaluation

  3weeks

• the grading of constipation ,diarrhea and decrease in appetite

  3weeks

• Electrogastrogram

  3weeks

• Hospital Anxiety and Depression Scale

  3weeks

• Functional Assessment of Cancer Treatment - General scale4.0

  3weeks

Other Outcomes (3)

• Number of Participants With Abnormal Laboratory Values

  6weeks

• cardial electrical activity

  6weeks

• other adverse effect during the chemotherapy

  6weeks

Study Arms (2)

Electroacupuncture Single point

EXPERIMENTAL

Single point PC6 means there is only one acupoint to be chosen: Neiguan(PC6)

Other: Single points PC6

Electroacupuncture Matching points

EXPERIMENTAL

There are three acupoints to be chosen:Bilateral Neiguan(PC6)and Zhongwan(CV12)

Other: Matching points PC6+CV12

Interventions

Matching points PC6+CV12 OTHER

Choose both Neiguan(PC6) and Zhongwan point(CV12).The needles are connected through a electro-acupuncture apparatus, the positive poles are linked to the needle, and the reference poles are located near the acupoint about 1cm with a electrode.Frequency is 2/10 hertz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10 milliampere. And plus 5-hydroxytryptamine-3 (5-HT3) antagonist (Ramosetron, Tropisetron，Granisetron or Ondansetron) and dexamethasone.

Electroacupuncture Matching points

Single points PC6 OTHER

Choose Neiguan(PC6)of double upper limb.The needles are connected through a electro-acupuncture apparatus, the positive poles are linked to the needle, and the reference poles are located near the acupoint about 1cm with a electrode.Frequency is 2/10 hertz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10 milliampere. And plus 5-hydroxytryptamine-3 (5-HT3) antagonist (Ramosetron, Tropisetron，Granisetron or Ondansetron) and dexamethasone.

Electroacupuncture Single point

Eligibility Criteria

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

You may qualify if:

• Be diagnosed as cancer and need to accept chemotherapy
• The score of Karnofsky ≥70
• Patients of either gender and age 18 years to 80 years
• Patients receiving chemotherapy both outpatients and inpatients
• Patients receiving chemotherapy regime with high risk of causing vomiting: cisplatin ≥60 mg/m2, or joint chemotherapy regime of Anthracyclines (Adriamycin≥ 40 mg/ m2 or epirubicin≥60 mg/m2), Dacarbazine or Carboplatin（area under the curve greater than 5mg/ml/min）
• Life expectancy \> 6 months

You may not qualify if:

• To receive radiotherapy and chemotherapy
• Gastrointestinal tumors
• Patients with serious liver disease or abnormal hepatorenal function (Aspartate Aminotransferase, Alanine Aminotransferase , and Total Bilirubin are 3 times more than normal, blood urea nitrogen and Cr are 2 times more than normal)
• Presence of cardiac pacemaker
• Inflammatory skin reaction
• Nausea and/or vomiting resulting from opioids or metabolic imbalance (electrolytic disturbances)
• Patients unable to provide self-care or communication
• Nausea and/or vomiting resulting from mechanical risk factors (i.e.,intestinal obstruction)
• Patients with brain metastases or symptoms of intracranial hypertension
• Nausea and/or vomiting resulting from other diseases(i.e.,sympathetic cervical dispositions, Meniere's syndrome)
• Women in pregnant and lactating period
• Refusal to sign informed consent, rejection of randomization into intervention groups.

Sponsors & Collaborators

• Tianjin University of Traditional Chinese Medicine: lead
• National Basic Research Program, China: collaborator
• West China Hospital: collaborator
• Tianjin Medical University Cancer Institute and Hospital: collaborator
• Gansu Provincial Cancer Hospital: collaborator
• Henan Provincial People's Hospital: collaborator

Study Sites (1)

Tianjin University of TCM

Tianjin, Tianjin Municipality, 300193, China

RECRUITING

MeSH Terms

Conditions

Vomiting

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 5, 2017
• First Posted: February 23, 2017
• Study Start: February 17, 2017
• Primary Completion: April 28, 2018
• Study Completion: May 28, 2018
• Last Updated: February 9, 2018

Record last verified: 2018-02

Locations

CN (1)