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The Effect and Mechanism of Electroacupuncture on Acute Chemotherapy-induced Nausea and Vomiting

Primary Purpose

Lung Neoplasms

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
acupuncture (Huatuo)
Sponsored by
Xidian University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lung Neoplasms

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • First diagnosed stage Ⅲ-Ⅳ lung cancer patients on cisplatin chemotherapy;
  • Right-handed and aged 18 to 75 years;
  • Karnosky performance status (KPS) ≥ 70;
  • Life expectancy ≥ 6 months.

Exclusion Criteria:

  • Had brain metastases or other concurrent life-threatening diseases;
  • Nausea and/or vomiting were present 24h before chemotherapy treatment;
  • Suffered from or had a history of gastrointestinal diseases;
  • Had a history of head trauma, serious neurological or psychiatric disorders;
  • Participating in other clinical trials currently;
  • Had any contraindication to exposure to a high magnetic field or receive acupuncture

Sites / Locations

  • Xijing HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Sham Comparator

No Intervention

Arm Label

Acupuncture 1

Acupuncture 2

Sham acupuncture

Waitinglist control

Arm Description

In this group, patients separately received twice electroacupuncture at bilateral PC6 acupoint before and after Cisplatin administration on the first day of chemotherapy.

In this group, patients separately received twice electroacupuncture at bilateral PC6 and RN12 acupoints before and after Cisplatin administration on the first day of chemotherapy.

In this group, patients separately received twice electroacupuncture at bilateral nonacupuncture point (S1 located at lateral of flexor carpi radialis, 2 cun above the wrist. S2 located at 3 cun right side of RN12) before and after Cisplatin administration on the first day of chemotherapy.

In this group, patients received no electroacupuncture

Outcomes

Primary Outcome Measures

The scores of Rhodes Index of Nausea, Vomiting and Retching.

Secondary Outcome Measures

Content of 5-hiaa in urine
Heart Rate Variability
Tachygastria percentage
Dosage of antiemetic drugs

Full Information

First Posted
June 8, 2015
Last Updated
June 18, 2015
Sponsor
Xidian University
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1. Study Identification

Unique Protocol Identification Number
NCT02469493
Brief Title
The Effect and Mechanism of Electroacupuncture on Acute Chemotherapy-induced Nausea and Vomiting
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xidian University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to compare the preventive effect of electroacupuncture and sham acupuncture on acute chemotherapy-induced nausea and vomiting and then investigate its potential mechanism by using functional Magnetic Resonance Imaging (fMRI).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture 1
Arm Type
Experimental
Arm Description
In this group, patients separately received twice electroacupuncture at bilateral PC6 acupoint before and after Cisplatin administration on the first day of chemotherapy.
Arm Title
Acupuncture 2
Arm Type
Experimental
Arm Description
In this group, patients separately received twice electroacupuncture at bilateral PC6 and RN12 acupoints before and after Cisplatin administration on the first day of chemotherapy.
Arm Title
Sham acupuncture
Arm Type
Sham Comparator
Arm Description
In this group, patients separately received twice electroacupuncture at bilateral nonacupuncture point (S1 located at lateral of flexor carpi radialis, 2 cun above the wrist. S2 located at 3 cun right side of RN12) before and after Cisplatin administration on the first day of chemotherapy.
Arm Title
Waitinglist control
Arm Type
No Intervention
Arm Description
In this group, patients received no electroacupuncture
Intervention Type
Device
Intervention Name(s)
acupuncture (Huatuo)
Intervention Description
The needles used were Huatuo brand (Suzhou, China) sterile disposable stainless steel filiform; needles sized 0.25*25 mm. After disinfection, needles were inserted 0.5 to 0.8 inches into the skin and were manipulated manually to obtain Deqi. An electric stimulator (Huatuo SDZ-V, Suzhou, China) was connected to the needles and delivered a constant-current, 0.2-ms, density-wave, stimulus of 2 to 10-Hz frequency, level of intensity was as much as tolerable, but not painful to the subjects. The needles were left for 30 minutes and then removed.
Primary Outcome Measure Information:
Title
The scores of Rhodes Index of Nausea, Vomiting and Retching.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Content of 5-hiaa in urine
Time Frame
12 hours
Title
Heart Rate Variability
Time Frame
1 hour
Title
Tachygastria percentage
Time Frame
1 hour
Title
Dosage of antiemetic drugs
Time Frame
24 hours
Other Pre-specified Outcome Measures:
Title
Neuroimaging data
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: First diagnosed stage Ⅲ-Ⅳ lung cancer patients on cisplatin chemotherapy; Right-handed and aged 18 to 75 years; Karnosky performance status (KPS) ≥ 70; Life expectancy ≥ 6 months. Exclusion Criteria: Had brain metastases or other concurrent life-threatening diseases; Nausea and/or vomiting were present 24h before chemotherapy treatment; Suffered from or had a history of gastrointestinal diseases; Had a history of head trauma, serious neurological or psychiatric disorders; Participating in other clinical trials currently; Had any contraindication to exposure to a high magnetic field or receive acupuncture
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jin, Doctor
Email
king-jlm@163.com
Facility Information:
Facility Name
Xijing Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang
Phone
86(029)-84775343

12. IPD Sharing Statement

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The Effect and Mechanism of Electroacupuncture on Acute Chemotherapy-induced Nausea and Vomiting

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