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Electroacupuncture Therapy for Chronic Pain After Breast Cancer Treatment

Phase 2
Waitlist Available
Led By Lorenzo Cohen
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have persistent pain (unrelated to aromatase inhibitors or chemotherapy-induced peripheral neuropathy) for at least 3 months following treatment for breast cancer
Have worst pain >= to 4 (0-10 numeric rating scale [NRS]) in the preceding week
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline
Awards & highlights

Study Summary

This trial looks at how well electroacupuncture therapy can help to reduce chronic pain in patients who have had surgery for breast cancer.

Who is the study for?
This trial is for adult women over 18 who've had stage I-III breast cancer surgery and completed treatment at least 4 months ago. They must have chronic pain post-treatment, speak English, and be able to follow the study plan. Excluded are those with pacemakers, recent acupuncture treatments, bleeding disorders, or metastatic breast cancer.Check my eligibility
What is being tested?
The trial tests if electroacupuncture can reduce chronic pain in patients after breast cancer surgery. It involves sending electrical pulses through needles into the skin. Participants will also undergo lab marker analysis and complete quality-of-life assessments.See study design
What are the potential side effects?
Electroacupuncture may cause minor side effects like bruising or soreness where the needles enter the skin, mild bleeding, dizziness during treatment, or an allergic reaction to stainless steel needles.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had pain for over 3 months after my breast cancer treatment, not due to medication or nerve damage from chemotherapy.
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My worst pain in the last week was 4 or more on a scale of 0 to 10.
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I finished all my cancer treatments at least 4 months ago.
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I have had stage I, II, or III breast cancer in the past.
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I am managing my lymphedema symptoms at home.
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I am a woman aged 18 or older.
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My current tests show no signs of cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in pain scores assessed by Brief Pain Inventory (BPI)
Secondary outcome measures
Baseline expectancy of participants will be correlated to the outcomes response.
Caregiver Reaction Assessment (CRA) Questionnaire
Change in autotaxin (ATX)/lysophosphatidic acid (LPA) axis
+8 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Group I (electroacupuncture therapy)Experimental Treatment4 Interventions
Patients undergo electroacupuncture therapy over 45 minutes 2-3 times per week over 4 weeks for a total of 10 sessions.
Group II: Group III (waitlist control)Active Control3 Interventions
Patients receive standard of care without any kind of acupuncture therapy.
Group III: Group II (sham electroacupuncture therapy)Placebo Group4 Interventions
Patients undergo modified electroacupuncture therapy over 45 minutes 2-3 times per week over 4 weeks for a total of 10 sessions. Acupuncture needles are placed in different locations using a different technique than those used for Group I.

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,338 Total Patients Enrolled
148 Trials studying Breast Cancer
63,286 Patients Enrolled for Breast Cancer
Gateway for Cancer ResearchOTHER
45 Previous Clinical Trials
2,459 Total Patients Enrolled
6 Trials studying Breast Cancer
351 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,535 Total Patients Enrolled
939 Trials studying Breast Cancer
1,543,333 Patients Enrolled for Breast Cancer

Media Library

Electroacupuncture Therapy (Other) Clinical Trial Eligibility Overview. Trial Name: NCT02754752 — Phase 2
Breast Cancer Research Study Groups: Group III (waitlist control), Group I (electroacupuncture therapy), Group II (sham electroacupuncture therapy)
Breast Cancer Clinical Trial 2023: Electroacupuncture Therapy Highlights & Side Effects. Trial Name: NCT02754752 — Phase 2
Electroacupuncture Therapy (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02754752 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any short-term or long-term risks associated with Electroacupuncture Therapy?

"While there is some evidence that Electroacupuncture Therapy may be safe, Phase 2 trials have not yet demonstrated any efficacy."

Answered by AI

Are we currently enrolling people for this research project?

"The study, which is currently looking for participants, was first posted on clinicaltrials.gov on September 13th 2016. The 3/3/2021 update was the most recent one as of this writing."

Answered by AI

How many enrollees does this clinical trial have thus far?

"The clinical trial is presently searching for patients, as indicated by information on clinicaltrials.gov. The initial posting date was 9/13/2016, with the most recent edit being 3/3/2021. 109 participants are needed at 1 location."

Answered by AI
~10 spots leftby Dec 2024