The use of electroacupuncture with chemotherapy for early stage breast cancer : evaluating feasibility and safety

Phase 2

Recruiting

• Conditions: Early stage breast cancer; Cancer - Breast; Electroacupuncture; Alternative and Complementary Medicine - Other alternative and complementary medicine

• Registration Number: ACTRN12608000031369
• Lead Sponsor: Sydney Cancer Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-01-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 30

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

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)[At conclusion of study (expected duration for target recruitment is 18 months)];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)[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 Measures

Name	Time	Method
Incidence and duration of chemotherapy related nausea, as measured by MASCC (Multinational Association for Supportive Care in Cancer) antiemesis tool[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)];Incidence and duration of chemotherapy related acute and delayed vomiting, as measured by MASCC (Multinational Association for Supportive Care in Cancer)antiemesis tool[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)];Incidence and duration of chemotherapy induced neutropenia, measured by blood tests on days 1,12,22,33,43[Days 22 and 43 for each participant; Final assessment at conclusion of study (expected duration for target recruitment is 18 months)]