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Ear Acupuncture for Breast Cancer
N/A
Waitlist Available
Led By Weidong Lu, MB, MPH, PhD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the activation of the study to the completion of the recruitment, 6 months.
Awards & highlights
Study Summary
This trial is testing if ear acupuncture can help reduce chemotherapy side effects.
Who is the study for?
This trial is for adults over 18 with Stage I-III breast cancer who are getting chemotherapy every two or three weeks. They should be in good physical condition and not have used acupuncture recently. It's not for those with weekly chemo, recent heart issues, metastatic cancer, severe psychiatric disorders, uncontrolled infections or seizures, or if pregnant.Check my eligibility
What is being tested?
The study is looking at whether ear acupuncture can help reduce symptoms that come from receiving chemotherapy in breast cancer patients. Participants will receive ear acupuncture during their regular chemotherapy sessions.See study design
What are the potential side effects?
Ear acupuncture may cause minor side effects such as slight pain where the needles enter the skin, bleeding, bruising, dizziness or fainting. However, it's generally considered a low-risk procedure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the activation of the study to the completion of the recruitment, 6 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the activation of the study to the completion of the recruitment, 6 months.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Treatment-related Adverse Events (Safety)
The numbers of study patients being recruited and retained (Feasibility)
Secondary outcome measures
Changes in Edmonton Symptom Assessment System (ESAS) score relative to Baseline
Changes in State-Trait Anxiety Inventory (STAI) score relative to Baseline
Side effects data
From 2013 Phase 1 & 2 trial • 104 Patients • NCT013058112%
Serious unexpected
2%
Pain on needling
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bi-Weekly Acupuncture
Wait List
Trial Design
1Treatment groups
Experimental Treatment
Group I: AcupunctureExperimental Treatment1 Intervention
Patients will receive a 30-minute session of a standardized ear acupuncture treatment Acupuncture needles will be gently manipulated to increase stimulation For each ear acupuncture session, the patient will have ear acupuncture therapy administered to each ear
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acupuncture
2011
Completed Phase 3
~1240
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Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,922 Total Patients Enrolled
141 Trials studying Breast Cancer
22,591 Patients Enrolled for Breast Cancer
Weidong Lu, MB, MPH, PhDPrincipal InvestigatorDana-Farber Cancer Institute
2 Previous Clinical Trials
122 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently getting chemotherapy every week.You have a history of receiving specific types of chemotherapy for early stage breast cancer.You have cancer that has spread to other parts of your body.You are in good enough health to carry out daily activities or you are mostly able to carry out daily activities.You have used acupuncture in the three months before the study starts.You have severe mental health conditions that are not being managed well.You have a serious, uncontrolled infection.You have seizures that are not well controlled.
Research Study Groups:
This trial has the following groups:- Group 1: Acupuncture
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies available for the clinical trial?
"Per the most recent information on clinicaltrials.gov, this trial is not actively seeking participants at this time. It was first posted in June 2017 and last updated on May 25th 2022; however, there are still 2602 other trials searching for volunteers."
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