NCT02469493

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).

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 11, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Last Updated

June 22, 2015

Status Verified

June 1, 2015

Enrollment Period

2.5 years

First QC Date

June 8, 2015

Last Update Submit

June 18, 2015

Conditions

Lung Neoplasms

Outcome Measures

Primary Outcomes (1)

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

    24 hours

Secondary Outcomes (4)

  • Content of 5-hiaa in urine

    12 hours

  • Heart Rate Variability

    1 hour

  • Tachygastria percentage

    1 hour

  • Dosage of antiemetic drugs

    24 hours

Other Outcomes (1)

  • Neuroimaging data

    24 hours

Study Arms (4)

Acupuncture 1

EXPERIMENTAL

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

Device: acupuncture (Huatuo)

Acupuncture 2

EXPERIMENTAL

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.

Device: acupuncture (Huatuo)

Sham acupuncture

SHAM COMPARATOR

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.

Device: acupuncture (Huatuo)

Waitinglist control

NO INTERVENTION

In this group, patients received no electroacupuncture

Interventions

acupuncture (Huatuo)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 1Acupuncture 2Sham acupuncture

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Central Study Contacts

Jin, Doctor

CONTACT

king-jlm@163.com

Study Design

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

Study Record Dates

First Submitted

June 8, 2015

First Posted

June 11, 2015

Study Start

January 1, 2015

Primary Completion

July 1, 2017

Last Updated

June 22, 2015

Record last verified: 2015-06

Locations

CN(1)