Clinical trial NCT02821442: "Electro Acupuncture in the Treatment and Management of Chemotherapy Induced Peripheral Neuropathy"
Official title: "Electro Acupuncture in the Treatment and Management of Chemotherapy Induced Peripheral Neuropathy"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: Electroacupuncture
Neuropathic Pain
Chemotherapy Induced Peripheral Neuropathy
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: CancerCare Manitoba
First posted: 2016-07-01
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: S-Lanss (short- Leads assessment of neuropathic symptoms and signs)
timeFrame: 2 years
measure: VAS (Visual Analogue Scale)
timeFrame: 2 years
measure: DASH (Disabilities of the arm, shoulder, hand)
timeFrame: 2 years
measure: LEFS (Lower extremity functional scale)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Barbara Shay, PhD
role: PRINCIPAL_INVESTIGATOR
References: