Your session is about to expire
← Back to Search
Acupuncture for Breast Cancer-Related Cognitive Difficulties
Phase 2
Recruiting
Led By Jun Mao, MD, MSCE
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Free of oncologic disease by clinical examination or history
Presence of insomnia symptoms as indicated by a score ≥8 on the ISI134
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 26 weeks
Awards & highlights
Study Summary
This trial is testing whether acupuncture can help breast cancer survivors with cognitive difficulties and insomnia. Patients will be randomly assigned to real acupuncture, placebo acupuncture, or wait-list acupuncture. There will be cognitive testing and questionnaires at different intervals to assess the effects of acupuncture.
Who is the study for?
This trial is for English-speaking adult women who've had stage 0-III breast cancer, are currently free of cancer, and have noticed a decline in memory or mental ability since their diagnosis. They should be experiencing insomnia and cognitive difficulties but not taking certain medications or undergoing other treatments that could affect the study's outcome.Check my eligibility
What is being tested?
The study tests if acupuncture can help with cognitive issues and sleep problems after breast cancer treatment. It compares real acupuncture to placebo (fake) acupuncture and no treatment at all. Participants will answer questionnaires and undergo cognitive testing over several weeks to measure changes.See study design
What are the potential side effects?
Acupuncture may cause minor side effects like bruising, bleeding at needle sites, dizziness, or fainting. However, it's generally considered safe when performed by a trained practitioner.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I currently have no signs of cancer based on exams or my medical history.
Select...
I have insomnia with a score of 8 or higher on the ISI.
Select...
I am an English-speaking woman who has had stage 0 to III breast cancer.
Select...
I often or very often have trouble with my memory or concentration.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 26 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~26 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
cognitive difficulties
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Wait-List ControlExperimental Treatment2 Interventions
During the 26-week waiting period, the CRC will contact patients in the WLC group at the same frequency as the acupuncture groups with respect to data collection. Patients in the WLC group will continue to receive their standard medical care as prescribed by their oncologists/primary care physicians. WLC patients will be compensated with real acupuncture treatments after Week 26 (end of study).
Group II: AcupunctureExperimental Treatment2 Interventions
The intervention will consist of 10 acupuncture sessions over 10 weeks using the standardized, semi-fixed protocol.
Group III: Sham Acupuncture (SA)Placebo Group2 Interventions
The intervention will consist of 10 acupuncture sessions over 10 weeks using the standardized, semi-fixed protocol.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acupuncture
2011
Completed Phase 3
~1240
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,937 Previous Clinical Trials
588,017 Total Patients Enrolled
202 Trials studying Breast Cancer
80,823 Patients Enrolled for Breast Cancer
Jun Mao, MD, MSCEPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
9 Previous Clinical Trials
1,760 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I finished my surgery, chemotherapy, or radiation less than a month ago.You have a mental health condition that is not currently under control.I do not have any severe vision or hearing problems that would stop me from completing health assessments.I am willing to follow the study's procedures and accept any of the three treatment options.I currently have no signs of cancer based on exams or my medical history.You have experienced a decline in your ability to think clearly since being diagnosed with cancer.I haven't started or changed any hormone or targeted therapy in the last 4 weeks.I have insomnia with a score of 8 or higher on the ISI.My breast cancer has spread to other parts of my body.I have had a stroke or head injury that needed ER visit or hospital stay, with lasting cognitive issues.I plan to start or change my hormone or targeted therapy soon.I am unable to understand and give consent for treatment on my own.I am an English-speaking woman who has had stage 0 to III breast cancer.I haven't changed my sleep or mood medication doses in the last 8 weeks.My health issues affect my work or home responsibilities.I often or very often have trouble with my memory or concentration.I have used acupuncture for sleep or cognitive issues in the last 3 months.I have been diagnosed with a brain disorder such as Alzheimer's or Parkinson's.It has been over 10 years since my last breast cancer diagnosis.I feel my memory or mental ability has declined since my cancer diagnosis.You feel like your memory or thinking ability has declined since you were diagnosed with cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Acupuncture
- Group 2: Wait-List Control
- Group 3: Sham Acupuncture (SA)
Awards:
This trial has 0 awards, including: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.
Breast Cancer Patient Testimony for trial: Trial Name: NCT04837820 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA given Acupuncture their stamp of approval?
"While there is some data supporting acupuncture's safety, none of it suggests that the medical intervention is effective. As such, Power rated it a 2."
Answered by AI
Are patients being accepted into the trial at this time?
"From what is available on clinicaltrials.gov, it appears that this study is still looking for participants and actively recruiting them. The trial was first posted on April 6th, 2021 with the most recent edit taking place on October 19th, 2022."
Answered by AI
Who else is applying?
What state do they live in?
New Jersey
What site did they apply to?
Memorial Sloan Kettering Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
Acupuncture is the only solution that has been working to reduce the tumor in my breast.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
How long is this trial?
PatientReceived no prior treatments
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger