None listed
Conditions
Brief summary
This study will be investigating the effectiveness of electroacupuncture in treating chemotherapy-induced peripheral neuropathy (CIPN) during paclitaxel chemotherapy for breast cancer patients. Who is it for? You may be eligible for this study if you are an adult female who has been diagnosed with stage I-III breast cancer and have been scheduled to receive weekly adjuvant or neoadjuvant paclitaxel treatments Study details Participants will be randomly allocated to receive 10 weekly sessions of either electroacupuncture or sham electroacupuncture. Feasibility and acceptability of the intervention, as well as any changes in CIPN symptoms, will be assessed over the course of the study. It is hoped that information from this study will inform researchers of any potential benefits that electroacupuncture has for treatment of CIPN.
Interventions
The study intervention consists of electroacupuncture (EA) administered once a week over ten weeks, with a total of 10 treatments for each participant. The participants will receive EA at the following locations: upper limb - LI4, TE6, Baxie (M-UE-22) and lower limb - ST36, LR3, bafeng (M-LE-8). The needles in the webs of the toes and fingers will be inserted to the depth of between 5 to 10mm at (Baxie and Bafeng acupoints) and 10 – 13mm at the remaining acupoints. Single-use disposable stainles
The study intervention consists of electroacupuncture (EA) administered once a week over ten weeks, with a total of 10 treatments for each participant. The participants will receive EA at the following locations: upper limb - LI4, TE6, Baxie (M-UE-22) and lower limb - ST36, LR3, bafeng (M-LE-8). The needles in the webs of the toes and fingers will be inserted to the depth of between 5 to 10mm at (Baxie and Bafeng acupoints) and 10 – 13mm at the remaining acupoints. Single-use disposable stainless steel Dongbang needles (0.20 x 15mm) will be used. Leads from the EA machine (ITO Co Ltd, 143609 Acuneeds Australia Pty LtD – stimulator, electrical, acupuncture) will be placed on the points Baxie and Bafeng. The electrostimulation will be delivered at a low frequency (2 Hz), on a disperse continuous setting, with moderate intensity. Duration of each treatment will be 45 minutes where the intervention will be administered by a registered acupuncturist with oncology experience. The timing of intervention administration will be timed +/- 2 days pre-infusion (weekly), this will usually be the same day as routine blood test prior to infusion. Adherence to the intervention will be monitored with a session attendance checklist, which will also be checked weekly.
Sponsors
Chris O'Brien Lifehouse Surfebruary Cancer Research Fund
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age - greater than or equal to 18 years old 2. Stage I-III breast cancer. 3. Scheduled to receive weekly adjuvant or neoadjuvant paclitaxel treatments.
Exclusion criteria
1. Prior use of acupuncture for CIPN on more than one occasion within 6 months prior to commencement of the study. 2. Peripheral neuropathy due to a pre-existing condition prior to chemotherapy (e.g., including alcoholism, diabetic, congenital neuropathy, toxic neuropathy, nerve compression or injury, neuroma). 3. Presentation of autonomic related CIPN symptoms
Outcome results
None listed