Electroacupuncture for taxane-induced peripheral neuropathy in patients with Breast Cancer during treatment

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2022
INTERVENTION: 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. CONDITION: Cancer ‐ Breast chemotherapy‐induced peripheral neuropathy; ; chemotherapy‐induced peripheral neuropathy Neurological ‐ Other neurological disorders PRIMARY OUTCOME: Adherence rate ‐ Proportion of participants who complete 7 out of 10 planned study treatments[At the conclusion of study] Recruitment rate ‐ the number of participants recruited per month assessed by audit of study records [At the conclusion of study] Successful blinding of participants ‐ Proportion of participants who correctly identify intervention received (i.e., EA or sham‐EA) at final (10th) treatment assessed by study‐specific questionnaire[After the final (10th) treatment] SECONDARY OUTCOME: Change in CIPN symptoms as measured by summary scores of EORTC QLQ‐CIPN20 ‐ From randomisation to end of week 12 of paclitaxel treatment[Weekly measures, at randomisation to end of week 12 of paclitaxel treatment] Sustained change in CIPN symptoms as measured by summary scores of EORTC QLQ‐CIPN20 [Measured at 8 weeks and 24 weeks follow up after completion of 12th paclitaxel treatment] The number of CIPN related dose modifications or treatment delays ‐ based on patient electronic medical records[At time of final taxane treatment (12th paclitaxel treatment)] 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.
Epistemonikos ID: cc56b7bb2296fafb2ffdaf98d15bde6d9c7bafe2
First added on: Aug 25, 2024