Breast Cancer
Conditions
Keywords
Electroacupuncture, Neuropathic Pain, Chemotherapy Induced Peripheral Neuropathy
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.
Interventions
DEVICEAcupuncture
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
DEVICESham Acupuncture
Placebo needles appear to penetrate but do not actually penetrate the skin
Sponsors
CancerCare Manitoba
University of Manitoba
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| S-Lanss (short- Leads assessment of neuropathic symptoms and signs) | 2 years | 16 point pain questionnaire that differentiates nociceptive from neuropathic pain |
| VAS (Visual Analogue Scale) | 2 years | 10 point verbal rating pain scale to measure participants pain in each assessment |
| DASH (Disabilities of the arm, shoulder, hand) | 2 years | 30 item questionnaire measuring upper limb function |
| LEFS (Lower extremity functional scale) | 2 years | 20 item questionnaire measuring lower limb function |
Countries
Canada
Contacts
Primary ContactElizabeth Hammond, M.Sc.
Backup ContactBarbara Shay, PhD
Outcome results
None listed