None listed
Conditions
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.
Interventions
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
Sponsors
Sydney Cancer Centre
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed