"Electro Acupuncture in the Treatment and Management of Chemotherapy Induced Peripheral Neuropathy"
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- University of Manitoba
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- S-Lanss (short- Leads assessment of neuropathic symptoms and signs)
- Last Updated
- 8 years ago
Overview
Brief 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.
Investigators
Barbara Shay
Associate Professor, Department head, College of Rehabilitation Sciences
University of Manitoba
Eligibility Criteria
Inclusion Criteria
- •Any patient diagnosed with stage 1-3 breast cancer who has finished chemotherapy 6 months prior and has residual CIPN symptoms graded as a 3/10 or higher on the numeric rating pain scale.
Exclusion Criteria
- •Patients who have co-morbid conditions that cause peripheral neuropathic symptoms
- •patients with heart valve replacements
- •patients on prophylactic antibiotics
- •patients with severe coagulopathy
- •patients who did not receive regular taxane therapy
Outcomes
Primary Outcomes
S-Lanss (short- Leads assessment of neuropathic symptoms and signs)
Time Frame: 2 years
16 point pain questionnaire that differentiates nociceptive from neuropathic pain
VAS (Visual Analogue Scale)
Time Frame: 2 years
10 point verbal rating pain scale to measure participants pain in each assessment
LEFS (Lower extremity functional scale)
Time Frame: 2 years
20 item questionnaire measuring lower limb function
DASH (Disabilities of the arm, shoulder, hand)
Time Frame: 2 years
30 item questionnaire measuring upper limb function