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

NCT ID: NCT02469493

Last Updated: 2015-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Brief Summary

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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).

Detailed Description

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Conditions

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Lung Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Acupuncture 1

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

Group Type EXPERIMENTAL

acupuncture (Huatuo)

Intervention Type DEVICE

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.

Acupuncture 2

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.

Group Type EXPERIMENTAL

acupuncture (Huatuo)

Intervention Type DEVICE

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.

Sham acupuncture

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.

Group Type SHAM_COMPARATOR

acupuncture (Huatuo)

Intervention Type DEVICE

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.

Waitinglist control

In this group, patients received no electroacupuncture

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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acupuncture (Huatuo)

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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xidian University

OTHER

Sponsor Role lead

Responsible Party

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Wei Qin

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Xijing Hospital

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jin, Doctor

Role: CONTACT

Facility Contacts

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Yang

Role: primary

86(029)-84775343

Other Identifiers

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2014CB543203

Identifier Type: -

Identifier Source: org_study_id

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