Electroacupuncture Therapy in Reducing Chronic Pain in Patients After Breast Cancer Treatment (NCT02754752) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Electroacupuncture Therapy in Reducing Chronic Pain in Patients After Breast Cancer Treatment
United States111 participantsStarted 2016-09-13
Plain-language summary
This randomized phase II trial studies how well electroacupuncture therapy works in reducing chronic pain in patients following surgery for stage I-III breast cancer. Electroacupuncture therapy is a type of complementary integrative medicine in which pulses of weak electrical current are sent through very thin, solid, sterile, stainless steel needles into certain points in the skin. Electroacupuncture therapy may help to lower pain and other surgery-related symptoms.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Be adult women \>/= 18 years of age.
* Be able to read, write, and speak English
* Able to give informed consent
* Have a history of stage I, II, or III breast cancer
* Have a documented visit with an oncologist during the previous 12-months
* Have no current evidence of disease
* Have persistent pain (unrelated to aromatase inhibitors or chemotherapy-induced peripheral neuropathy) for at least 3 months following treatment for breast cancer
* Have pain severity (arithmetic mean of four pain severity items) \>= 2 on Brief Pain Inventory (BPI)
* Have worst pain \>= to 4 (0-10 numeric rating scale \[NRS\]) in the preceding week
* Be willing and able to adhere to all study-related procedures
* Have completed all cancer treatment (including surgery, chemotherapy and/or radiation) at least 4 months prior to enrollment
* Have documented lab work with absolute neutrophil count (ANC) \>= 1.0 K/uL and platelets \>= 50 K/uL in the past 12 months
* If applicable, maintain self-management of lymphedema symptoms being performed at home at time of study entry
Exclusion Criteria:
* Metastatic breast cancer (stage IV)
* Known bleeding disorder per patient reported history
* Cardiac pacemaker or other implanted electronic devices
* New or planned new lymphedema treatment during the study period
* Currently receiving or ever received acupuncture for present pain condition
* Received acupuncture with electrical stimulation for any condition
* Received acupuncture for any…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in pain scores assessed by Brief Pain Inventory (BPI)