Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000031369
Ethics application status
Approved
Date submitted
15/01/2008
Date registered
21/01/2008
Date last updated
8/09/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
The use of electroacupuncture with chemotherapy for early stage breast cancer : evaluating feasibility and safety
Scientific title
A Randomised, Double-blind, Placebo Controlled Phase 2 trial to evaluate the Feasibility and Safety of Electroacupuncture when used in conjunction with chemotherapy for Early Stage Breast Cancer
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Early stage breast cancer 2712 0
Electroacupuncture 2724 0
Condition category
Condition code
Cancer 2833 2833 0 0
Breast
Alternative and Complementary Medicine 2845 2845 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Electroacupuncture will be delivered to four acupoints (PC6-pericardium 6, ST36-stomach 36, LI4-large intestine 4 & LIV3-liver 3) on days 1 and 2 of the first two cycles of chemotherapy. The duration of each session is approximately twenty minutes.
Chinese names of acupoints involved:
PC6-Neiguan, ST36-Zusanli, LI4-Hegu , LIV3-Taichong
Intervention code [1] 2462 0
Treatment: Devices
Comparator / control treatment
Treatment with identical specially designed sham acupuncture needles (which are non-skin penetrating and will automatically retract on contact with the skin) at four points, close to the real acupoints, to produce pinpoint pressure sensation. The electroacupuncture machine will deliver the same audiovisual stimuli as in the treatment arm, but lead wires will be concealed and disconnected so no electrical current is passed to the needles.
Control group
Placebo

Outcomes
Primary outcome [1] 3715 0
Feasibility of performing electroacupuncture when used in conjunction with chemotherapy for early stage breast cancer (Criteria rendering study feasible at conclusion: >80% of enrolled participants complete both cycles of chemotherapy within allocated intervention arm, as per preallocated treatment schedule)
Timepoint [1] 3715 0
At conclusion of study (expected duration for target recruitment is 18 months)
Primary outcome [2] 3716 0
Safety of Electroacupuncture when used in conjunction with chemotherapy for early stage breast cancer (Acceptable safety criteria: incidence of adverse reactions in study similar to or less than those documented in large series)
Timepoint [2] 3716 0
At end of 1st and 2nd cycles of chemotherapy (3 weeks & 6 weeks) for each participant; Final assessment at conclusion of study (expected duration for target recruitment is 18 months)
Secondary outcome [1] 6266 0
Incidence and duration of chemotherapy related nausea, as measured by MASCC (Multinational Association for Supportive Care in Cancer) antiemesis tool
Timepoint [1] 6266 0
At end of 1st and 2nd cycles of chemotherapy (3 weeks & 6 weeks) for each participant; Final assessment at conclusion of study (expected duration for target recruitment is 18 months)
Secondary outcome [2] 6267 0
Incidence and duration of chemotherapy related acute and delayed vomiting, as measured by MASCC (Multinational Association for Supportive Care in Cancer)antiemesis tool
Timepoint [2] 6267 0
At end of 1st and 2nd cycles of chemotherapy (3 weeks & 6 weeks) for each participant; Final assessment at conclusion of study (expected duration for target recruitment is 18 months)
Secondary outcome [3] 6268 0
Incidence and duration of chemotherapy induced neutropenia, measured by blood tests on days 1,12,22,33,43
Timepoint [3] 6268 0
Days 22 and 43 for each participant; Final assessment at conclusion of study (expected duration for target recruitment is 18 months)

Eligibility
Key inclusion criteria
Women receiving moderately emetogenic chemotherapy for early stage breast cancer with FEC (5-Fluorouracil, Epirubicin & Cyclophosphamide) or AC (Adriamycin & Cyclophosphamide);
Good performance status (fully active or if limited activity, then resting less than 50% of the time);
Normal organ and marrow function (haematological, renal and hepatic function);
Written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Any previous chemotherapy treatment;
Acupuncture treatment within the previous 4 weeks;
Existing peripheral neuropathy / neurological disorder / previous strokes;
Participants with a cardiac pacemaker or defibrillator or any other implanted or topical electrical device;
Active infection including active skin infection over proposed treatment area;
Non-chemotherapy induced emesis;
Uncontrolled severe intercurrent illness; Coagulation disorders including participants on warfarin or low molecular weight heparin;
Current regular use of antiemetics;
Needle phobia rendering participant unable to receive electroacupuncture

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)
Each eligible patient will be seen by a member of the research team and given verbal and written information abouth the study. After giving written consent, participants will be randomised (by computer generated codes) to either the treatment or placebo arm and given a sealed opaque envelope to be opened by the acupuncturist immediately prior to treatment. Participants and all research team clinicans (who will act as data collectors) will be blinded to the allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization by using a randomization table by a computer software (computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
24/01/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 551 0
2050

Funding & Sponsors
Funding source category [1] 2966 0
Self funded/Unfunded
Name [1] 2966 0
Country [1] 2966 0
Australia
Primary sponsor type
Hospital
Name
Sydney Cancer Centre
Address
Royal Prince Alfred Hospital,
Missenden rd, Camperdown,
NSW 2050
Country
Australia
Secondary sponsor category [1] 2677 0
None
Name [1] 2677 0
Address [1] 2677 0
Country [1] 2677 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4916 0
Sydney Southwest Area Health Service (RPAH zone) Ethics Review Committee
Ethics committee address [1] 4916 0
Royal Prince Alfred Hospital,
Missenden rd, Camperdown,
NSW 2050
Ethics committee country [1] 4916 0
Australia
Date submitted for ethics approval [1] 4916 0
Approval date [1] 4916 0
06/12/2007
Ethics approval number [1] 4916 0
07/RPAH/88

Summary
Brief summary
Background and Scientific basis:
Curative chemotherapy for early stage breast cancer has high incidence (>30%) of multiple side effects including nausea, vomiting and neutropenia (drop in white cells which counter infections). Current treatments to counter these have multiple side-effects and are expensive. In initial studies, concurrent use of acupuncture has shown some benefit in reducing these side-effects.
Aim & Hypothesis:
The primary objective is to evaluate the feasibility and safety of conducting this trial. The secondary objective is to assess any benefits of electroacupuncture for chemotherapy induced nausea, vomiting and neutropenia in women receiving chemotherapy for early stage breast cancer.
Study Population:
We will study women aged 18 years and over, receiving AC or FEC chemotherapy for early stage breast cancer, who are well with no other significant illness and provide written consent to participate in the trial. They will be provided verbal and written information about the study. Participation in this study is voluntary and women can withdraw at any time.
Women with certain conditions (existing neurological problems or strokes, cardiac pacemaker, defibrillator or any other implanted or topical electrical device, conditions causing excessive bleeding/bruising, regularly using medications for nausea/vomiting, women with fear of needles) will be excluded from the study.
Methods:
Participants will be randomly assigned to one of two groups, electroacupuncture treatment group or non-active/placebo group. Participants in the treatment group will receive electroacupuncture to four acupoints on days 1&2 for the first two cycles of chemotherapy. Participants in the placebo group will receive sham electroacupuncture via specially designed non-active devices at four points, close to the real acupoints. An experienced acupuncturist will perform the treatments in both groups. Neither the participant nor the doctors will know which group the participant is allocated to.
All participants will continue to receive usual medications for chemotherapy side-effects. Participants will be required to undergo routine blood tests, keep diary records of side-effects and answer short questionnaires during the study. The study duration for each participant is six weeks.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28297 0
Address 28297 0
Country 28297 0
Phone 28297 0
Fax 28297 0
Email 28297 0
Contact person for public queries
Name 11454 0
Dr. Jane Beith
Address 11454 0
Royal Prince Alfred Hospital,
Missenden rd, Camperdown,
NSW 2050
Country 11454 0
Australia
Phone 11454 0
+61 2 95156111
Fax 11454 0
Email 11454 0
Jane.Beith@sswahs.nsw.gov.au
Contact person for scientific queries
Name 2382 0
Dr. Jane Beith
Address 2382 0
Royal Prince Alfred Hospital,
Missenden rd, Camperdown,
NSW 2050
Country 2382 0
Australia
Phone 2382 0
+61 2 95156111
Fax 2382 0
Email 2382 0
Jane.Beith@sswahs.nsw.gov.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

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Documents added automatically
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