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Trial registered on ANZCTR


Registration number
ACTRN12609001054202
Ethics application status
Approved
Date submitted
2/12/2009
Date registered
9/12/2009
Date last updated
12/06/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Electroacupuncture for Chemotherapy Induced Nausea and Vomiting.
Scientific title
Electroacupuncture versus Sham Acupuncture and no Acupuncture for the Control of Acute and Delayed Chemotherapy Induced Nausea and Vomiting in patients with solid tumors.
Secondary ID [1] 1186 0
nil
Universal Trial Number (UTN)
U1111-1112-6845
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer - solid tumors 252329 0
Chemotherapy induced nausea and vomiting 252330 0
Condition category
Condition code
Cancer 252515 252515 0 0
Other cancer types
Alternative and Complementary Medicine 252516 252516 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Electroacupuncture,
Electroacupuncture at 4 acupuncture points bilaterally indicated for nausea and vomiting. Points are PC6, ST36, LV 3 and LI4. Sensi sterile acupuncture needles 0.20 x 30mm inserted and manipulated until "deqi" or a sensation is obtained. The frequency of the stimulation will be 10Hz and the intensity will be adjusted according to patient's tolerance (maximum 10 mA). Treatment will commence 10 minutes prior to chemotherapy starting and continue for further 20mins and will be repeated on Day 3. Patients recieve standard antiemetics as per protocols.
Intervention code [1] 255638 0
Treatment: Other
Comparator / control treatment
Sham acupuncture

Sham acupuncture will inserted adjacent to the true acupuncture point bya defined distance. Once the needles are inserted no further manipulation occurs. The electroacupuncture unit will be connected but will be non-functioning. Treatment is repeated on Day 3.

Contol Arm
Patients will receive standard treatment ie. normal antiemetic therapy and no acupunture.
Control group
Placebo

Outcomes
Primary outcome [1] 253405 0
Functional Living Index - Emesis score Day 7
Timepoint [1] 253405 0
Pre chemotherapy and Day 7 of chemotherapy treatment
Secondary outcome [1] 262495 0
Functional Living Index - Emesis score at day 4
Timepoint [1] 262495 0
Pre chemotherapy and Day 4 of chemotherapy treatment
Secondary outcome [2] 262496 0
Number of vomits day 1 -6 recorded in the daily patient diary.
Timepoint [2] 262496 0
Day 1, 2, 3, 4, 5 and 6 of chemotherapy treatment.
Secondary outcome [3] 262497 0
Nausea score Visual Analogue Scale (VAS) days 1-6 of chemotherapy treatment.
Timepoint [3] 262497 0
Day 1, 2, 3, 4, 5 and 6 of chemotherapy treatment.
Secondary outcome [4] 262498 0
Number of patients returning on Day 3.
Timepoint [4] 262498 0
Day 3 of chemotherapy treatment.
Secondary outcome [5] 262499 0
Number of patients recruited in 6 months
Timepoint [5] 262499 0
Assess at 6 months following enrolment of first patient.
Secondary outcome [6] 262500 0
Toxicity of acupuncture using modified National Cancer Institute Toxicity scale.
Timepoint [6] 262500 0
Assessed on Day 1, 3 and 7 for treatment arms

Eligibility
Key inclusion criteria
18 years and older
Receiving moderate to highly emetogenic chemotherapy.
Chemotherapy naive.
Solid tumors ( no haematological malignant disease)
A good understanding of English
Cognitive ability allowing for fully informed written consent and to complete all trial questionaires.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of acute, chronic or sub acute ileus
With thrombocytopenia (defined as platelet count <100)
Previous acupuncture for nausea and vomiting
Pre-existing nausea or vomiting from another medical condition.
Participating in any other trial, including those of new chemotherapy regimens
Concurrent treatment of chemotherapy and radiotherapy
Needle phobias
Insufficient understanding of the trial and its requirements

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patient allocation was done by sealed opaque envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a computerised sequence generator program
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 256121 0
Charities/Societies/Foundations
Name [1] 256121 0
Mater Foundation
Country [1] 256121 0
Australia
Funding source category [2] 256122 0
Commercial sector/Industry
Name [2] 256122 0
Australian Acupuncture and Chinese Medicine Assosciation
Country [2] 256122 0
Australia
Primary sponsor type
Hospital
Name
Mater Adults Hospital
Address
Raymond Terrace
South Brisbane, Qld 4101
Country
Australia
Secondary sponsor category [1] 251465 0
University
Name [1] 251465 0
University of Western Sydney
Address [1] 251465 0
Narellan Road
Campbelltown NSW 2560
Country [1] 251465 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258214 0
Mater Health Services Human Research Ethics Committee
Ethics committee address [1] 258214 0
Ethics committee country [1] 258214 0
Australia
Date submitted for ethics approval [1] 258214 0
15/10/2008
Approval date [1] 258214 0
25/02/2009
Ethics approval number [1] 258214 0
1276A

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30571 0
Address 30571 0
Country 30571 0
Phone 30571 0
Fax 30571 0
Email 30571 0
Contact person for public queries
Name 13818 0
Mr Chris McKeon
Address 13818 0
Level 10 Day Oncology Unit
Mater Adults Hospital
Raymond Terrace
South Brisbane Qld 4101
Country 13818 0
Australia
Phone 13818 0
+61(0)7 31631952
Fax 13818 0
Email 13818 0
chris.mckeon@mater.org.au
Contact person for scientific queries
Name 4746 0
Mr Chris McKeon
Address 4746 0
Level 10 Day Oncology Unit
Mater Adults Hospital
Raymond Terrace
South Brisbane Qld 4101
Country 4746 0
Australia
Phone 4746 0
+61 (0)731631952
Fax 4746 0
Email 4746 0
chris.mckeon@mater.org.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEA versus sham acupuncture and no acupuncture for the control of acute and delayed chemotherapy-induced nausea and vomiting: a pilot study.2015https://dx.doi.org/10.1136/acupmed-2015-010781
N.B. These documents automatically identified may not have been verified by the study sponsor.