"Electro Acupuncture in the Treatment and Management of Chemotherapy Induced Peripheral Neuropathy"
NCT ID: NCT02821442
Last Updated: 2018-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
30 participants
INTERVENTIONAL
2016-02-29
2018-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Exploratory Study of Electroacupuncture in the Treatment of Peripheral Neuropathy Induced by Platinum Based Chemotherapy Drugs
NCT03048591
Transcutaneous Electrical Acupoint Stimulation on Symptoms Associated with Chemotherapy Induced Peripheral Neuropathy
NCT05904340
Acupuncture in Chemotherapy-induced Peripheral Neuropathy in Women With Breast Cancer
NCT05673746
Effect of Adding Electroacupuncture to Anti-cancer Therapy-induced Peripheral Neuropathy
NCT06858709
Efficacy of Acupuncture on Chemotherapy-Induced Peripheral Neuropathy
NCT04739631
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Acupuncture
Acupuncture will consist of acupuncture points ST36, LR3, LI4 bilaterally x 30 minutes, once a week over 6 weeks. ST36 will have EA with 2Hz at the maximum tolerated intensity (ES-130 Portable Japanese Electro-Acupuncture Device, UPC Medical Supplies Inc. South El Monte, CA, USA).
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
Sham Acupuncture
Sham acupuncture (Streitberger Placebo Needles, Asiamed) uses the same points and treatment parameters but the placebo needle does not penetrate the skin and the current for EA is not turned on.
Sham Acupuncture
Placebo needles appear to penetrate but do not actually penetrate the skin
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Sham Acupuncture
Placebo needles appear to penetrate but do not actually penetrate the skin
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* patients with heart valve replacements
* patients on prophylactic antibiotics
* patients with severe coagulopathy
* patients who did not receive regular taxane therapy
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
CancerCare Manitoba
OTHER
University of Manitoba
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Barbara Shay
Associate Professor, Department head, College of Rehabilitation Sciences
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Barbara Shay, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Manitoba
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Manitoba
Winnipeg, Manitoba, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H2015:282
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.