NCT02821442

"Electro Acupuncture in the Treatment and Management of Chemotherapy Induced Peripheral Neuropathy"

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Manitoba · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

To evaluate the effectiveness of Electro acupuncture (EA) for treatment of persistent painful CIPN symptoms in patients with stages 1-3 breast cancer treated with docetaxel chemotherapy 6 months prior

Detailed description

A double blind prospective randomized controlled pilot study with cross over. To assess the effectiveness of EA in improving pain and function for chronic chemotherapy Induced Peripheral Neuropathy (CIPN) 30 participants will be recruited 6 months post-completion of chemotherapy. Fifteen participants will be randomized to the true EA group and 15 to the sham EA group. Those participants randomized to the sham group will cross over to receive true EA after the trial is complete. Treatment consists of EA or sham EA 1 x per week x 6 weeks. Re-assessment visits occur after the 6 week intervention and again 2 months post trial. Each assessment visit quantifies the sensory experience of CIPN at that moment in time using Quantitative Sensory Testing (QST) which includes; thermal detection and thermal pain thresholds, light touch detection using nylon monofilament hairs (Semmes Weinstein Monofilaments (SWMF)), static 2-point discrimination, pressure algometry and vibration thresholds. Patient reported outcome measures including the Disabilities of the Arm, Shoulder and Hand (DASH), Lower extremity functional score (LEFS), the Self report Leeds Assessment of Neuropathic signs and symptoms (S-LANSS) pain questionaire will also be used.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	Acupuncture	Acupuncture points selected on the arms and legs using both acupuncture and electroacupuncture to assess effectiveness in alleviating neuropathic pain caused by chemotherapy in breast cancer patients
DEVICE	Sham Acupuncture	Placebo needles appear to penetrate but do not actually penetrate the skin

Timeline

• Start date: 2016-02-01
• Primary completion: 2018-07-01
• Completion: 2018-12-01
• First posted: 2016-07-01
• Last updated: 2018-01-26

Locations

1 site across 1 country: Canada