Acupuncture for Breast Cancer-Related Cognitive Difficulties

Not currently recruiting at 7 trial locations

Overseen By Jun Mao, MD, MSCE

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Hypnotics, Sedatives, Antidepressants

Disqualifiers: Metastatic cancer, Alzheimer's, Stroke, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if acupuncture can improve memory and sleep issues in women who have survived breast cancer. Participants will receive either real acupuncture, placebo acupuncture (sham acupuncture), or be placed on a wait-list, with cognitive abilities tested throughout the study. Women who have experienced memory problems and insomnia since their breast cancer diagnosis are ideal candidates for this trial. After the trial, those who received placebo or were wait-listed can choose to receive real acupuncture treatments. As a Phase 2 trial, this research focuses on measuring acupuncture's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot participate if you've changed your dose of sleep-related medications in the past 8 weeks or plan to change them in the next 8 weeks.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you have changed the dose of sleep-related medications in the past 8 weeks, you may not be eligible.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that acupuncture is generally safe and well-tolerated for individuals experiencing cognitive difficulties due to breast cancer. Studies have found that acupuncture can help with mild thinking and memory problems related to cancer treatments. When performed by trained professionals, especially in cancer care settings, it is considered safe. No major reports of serious side effects have emerged from acupuncture in these situations. Overall, acupuncture is viewed as a safe option for improving symptoms related to cancer and its treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike standard treatments for breast cancer-related cognitive difficulties, which often involve medications or cognitive therapy, acupuncture offers a non-pharmacological approach. Researchers are excited about acupuncture because it uses a standardized protocol that may improve cognitive function by enhancing blood flow and balancing the body's energy systems without the side effects typical of medications. Additionally, the trial includes a sham acupuncture group to rigorously test the effectiveness of the treatment, potentially providing robust data on its benefits.

What evidence suggests that acupuncture might be an effective treatment for cognitive difficulties in breast cancer survivors?

Research suggests that acupuncture, which participants in this trial may receive, might help with memory and thinking problems in breast cancer survivors. Studies have shown that acupuncture can reduce side effects of cancer treatments, such as pain and nausea. Some researchers believe acupuncture works by boosting a protein called BDNF, which helps brain cells grow and stay healthy. This could explain why acupuncture might aid in alleviating thinking difficulties. Overall, evidence increasingly supports that acupuncture can improve brain function for those who have undergone cancer treatment. Participants in this trial may also receive Sham Acupuncture, serving as a placebo comparator. ^{2 5 6 7 8}

Who Is on the Research Team?

Jun Mao, MD, MSCE

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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.

Exclusion 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 10 acupuncture sessions over 10 weeks using a standardized, semi-fixed protocol

10 weeks

10 visits (in-person)

Follow-up

Participants are monitored for cognitive difficulties and insomnia through questionnaires and cognitive testing

16 weeks

Visits at Weeks 0, 4, 10, 14, and 26

Open-label extension (optional)

Participants in placebo or wait-list groups may receive up to 10 real acupuncture treatments within six months after the study

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Acupuncture
• Sham Acupuncture

Trial Overview 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.

How Is the Trial Designed?

Group I: Wait-List Control Experimental Treatment 2 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: Acupuncture Experimental Treatment 2 Interventions

The intervention will consist of 10 acupuncture sessions over 10 weeks using the standardized, semi-fixed protocol.

Group III: Sham Acupuncture (SA) Placebo Group 2 Interventions

The intervention will consist of 10 acupuncture sessions over 10 weeks using the standardized, semi-fixed protocol.

Acupuncture is already approved in United States, European Union, China for the following indications:

Approved in United States as Acupuncture for:

• Pain management
• Hot flashes
• Fatigue
• Sleep disturbances
• Anxiety
• Depression
• Neuropathy

Approved in European Union as Acupuncture for:

• Pain management
• Hot flashes
• Fatigue
• Sleep disturbances
• Anxiety
• Depression

Approved in China as Acupuncture for:

• Pain management
• Hot flashes
• Fatigue
• Sleep disturbances
• Anxiety
• Depression
• Neuropathy

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

Acupuncture and moxibustion may be effective treatments for chemotherapy-induced cognitive impairment (CICI), with a theoretical basis rooted in Traditional Chinese Medicine that links CICI to deficiencies in kidney and marrow, as well as liver qi stagnation.

Modern research suggests that acupuncture can have neuroprotective effects, potentially improving cognitive function by targeting specific brain areas like the cerebral cortex and hippocampus, although more studies are needed to confirm these benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The theoretical basis and acupoint selection of acupuncture treatment for "chemo brain"]. Lu, C., Chen, M., Zou, S.[2019]

In a study of 57 breast cancer patients undergoing radiotherapy, those receiving complementary alternative medicine (CAM) showed significant long-term improvements in attention performance compared to those receiving a placebo, indicating potential benefits of CAM in cognitive recovery.

Both groups exhibited similar anxiety levels throughout the study, suggesting that while CAM may enhance attention, it does not significantly impact anxiety during the radiotherapy period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attention Dysregulation in Breast Cancer Patients Following a Complementary Alternative Treatment Routine: A Double-Blind Randomized Trial. Dolev, T., Ben-David, M., Shahadi, I., et al.[2021]

Acupuncture may help reduce functional stiffness in breast cancer patients undergoing hormone therapy, based on a review of 17 randomized controlled trials involving 810 participants.

While acupuncture showed moderate effects on stiffness, it did not significantly alleviate other common side effects of hormone therapy, such as hot flashes and fatigue, indicating that its benefits may be limited to specific symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Benefits of Acupuncture for the Reduction of Hormone Therapy-Related Side Effects in Breast Cancer Patients: A Systematic Review. Pan, Y., Yang, K., Shi, X., et al.[2019]

In a study involving 93 breast cancer patients undergoing or post-chemotherapy, electroacupuncture trigeminal nerve stimulation plus body acupuncture (EA/TNS + BA) showed significant improvements in working memory, as measured by the reverse digit span test, compared to minimum acupuncture stimulation (MAS).

EA/TNS + BA also effectively reduced side effects such as diarrhea, poor appetite, headache, anxiety, and irritation, while enhancing overall emotional and social well-being, suggesting it could be a beneficial intervention for managing chemotherapy-related symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electroacupuncture trigeminal nerve stimulation plus body acupuncture for chemotherapy-induced cognitive impairment in breast cancer patients: An assessor-participant blinded, randomized controlled trial. Zhang, ZJ., Man, SC., Yam, LL., et al.[2021]

Acupuncture significantly reduces treatment-related symptoms such as pain intensity, fatigue, and hot flash severity in breast cancer survivors, based on a meta-analysis of 20 trials involving 1709 patients.

The treatment is generally safe, with only mild adverse events reported, but the studies had a high risk of bias, indicating a need for more rigorous trials to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture Improves Multiple Treatment-Related Symptoms in Breast Cancer Survivors: A Systematic Review and Meta-Analysis. Li, H., Schlaeger, JM., Jang, MK., et al.[2022]

A study involving 25 breast cancer survivors identified six key factors influencing their decision to participate in acupuncture clinical trials, including symptom appraisal, practical barriers, and beliefs about the treatment.

Both African-American and Caucasian participants considered similar factors, but they differed in their preferred information sources and concerns about placebo use, highlighting the need for tailored recruitment strategies in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast cancer survivors willingness to participate in an acupuncture clinical trial: a qualitative study. Schapira, MM., Mackenzie, ER., Lam, R., et al.[2022]

Between 20% and 50% of breast cancer patients experience cognitive dysfunction due to chemotherapy, and acupuncture may help alleviate these symptoms based on emerging research.

Acupuncture has shown promising efficacy in managing psychological issues, which could be beneficial for patients experiencing chemotherapy-related cognitive dysfunction, and it is considered safe, making it a viable option for patients with limited alternatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture for chemotherapy-associated cognitive dysfunction: a hypothesis-generating literature review to inform clinical advice. Johnston, MF., Yang, C., Hui, KK., et al.[2007]

Acupuncture has been found to provide moderate relief from hormone therapy-related side effects such as hot flashes, fatigue, and stiffness in breast cancer patients, based on a systematic review of randomized controlled trials.

Despite these positive findings, the evidence quality was downgraded due to inconsistencies and imprecision in the studies, highlighting the need for larger, more standardized trials to confirm acupuncture's efficacy and explore its biological mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture for Hormone Therapy-Related Side Effects in Breast Cancer Patients: A GRADE-Assessed Systematic Review and Updated Meta-Analysis. Yuanqing, P., Yong, T., Haiqian, L., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5963738/

Efficacy of Acupuncture Therapy for Chemotherapy-Related ... Conclusions. Acupuncture therapy is effective in the treatment of CRCI in breast cancer patients through a mechanism that may be related to an increase of BDNF.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02457039

Acupuncture Prevents Chemobrain in Breast Cancer Patients A large body of evidence well confirms that acupuncture is effective in reducing anti-cancer treatment-caused side effects, including pain, nausea, hot flashes, ...

3. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0318984

A systematic review and meta-analysis protocol | PLOS One Research indicates that acupuncture may serve as a promising intervention for CRCI. This study aims to assess the effectiveness of acupuncture in treating CRCI.

4. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2025.1565040/full

Effect and clinical mechanism exploration of acupuncture ... This randomized controlled trial aims to evaluate the effectiveness of acupuncture in managing CRCI among TNBC patients and explore the mechanism by which ...

5. ascopost.com ascopost.com/issues/october-25-2021/acupuncture-vs-cognitive-behavioral-therapy-for-cognitive-function-in-cancer-survivors-with-insomnia/

Acupuncture vs Cognitive Behavioral Therapy for ... The study seeks to evaluate the effects and mechanisms of acupuncture on cancer-related cognitive dysfunction in breast cancer survivors.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9134458/

Electroacupuncture for Cancer-Related Cognitive Impairment Our study results revealed that electroacupuncture improved cognitive complaints in cancer patients, and we expect electroacupuncture to be a safe and effective ...

7. withpower.com withpower.com/trial/phase-3-3-2021-24690

Acupuncture for Breast Cancer-Related Cognitive Difficulties What safety data exists for acupuncture in treating breast cancer-related cognitive difficulties? Acupuncture is generally considered safe for breast cancer ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2213422019300885

Evidence, safety and recommendations for when to use ... Acupuncture is a safe therapy in cancer care if administered by trained acupuncturists. Acupuncture is targeted to improve symptoms associated with the cancer ...