Acupuncture for Breast Cancer-Related Cognitive Difficulties

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

270 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to test whether acupuncture can improve cognitive difficulties and insomnia in survivors of breast cancer. Researchers will compare the effects of real acupuncture with those of placebo acupuncture and wait-list acupuncture. This study will also look at insomnia's link to cognitive difficulties. All study participants (receiving real acupuncture, placebo acupuncture, or wait-list acupuncture) will complete study questionnaires and/or have cognitive testing at Weeks 0, 4, 10, 14 and 26. After the Week 26 visit, your participation in this study will end. If you are assigned to receive placebo acupuncture or wait-list acupuncture, you will have the option of receiving up to 10 real acupuncture treatments within the six months after the study finishes.

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.

What data supports the idea that Acupuncture for Breast Cancer-Related Cognitive Difficulties is an effective treatment?

The available research shows that acupuncture may help manage cognitive difficulties related to breast cancer treatment. One study found that a specific type of acupuncture, called electroacupuncture trigeminal nerve stimulation plus body acupuncture, improved working memory and reduced symptoms like anxiety and headaches in breast cancer patients undergoing chemotherapy. Another review suggests that acupuncture can help with various treatment-related symptoms, such as fatigue and hot flashes, in breast cancer survivors. While more research is needed, these findings suggest acupuncture could be a helpful option for managing cognitive and other treatment-related difficulties in breast cancer patients. ^{1 2 3 4 5}

What data supports the effectiveness of acupuncture as a treatment for breast cancer-related cognitive difficulties?

Research suggests that acupuncture may help manage cognitive difficulties related to chemotherapy in breast cancer patients, as it has shown benefits in reducing symptoms like working memory impairment and improving emotional well-being. Additionally, acupuncture has been effective in alleviating other treatment-related symptoms such as fatigue and hot flashes, which may indirectly support its use for cognitive issues. ^{1 2 3 4 5}

What safety data exists for acupuncture in treating breast cancer-related cognitive difficulties?

Acupuncture is generally considered safe for breast cancer-related cognitive difficulties, with no serious adverse events reported in studies. Mild adverse events such as bruising, pain, swelling, skin infection, hematoma, headache, and menstrual bleeding have been noted. More rigorous trials are needed to confirm these findings, but current evidence suggests acupuncture is a safe treatment option. ^{1 2 4 5 6}

Is acupuncture safe for breast cancer-related cognitive difficulties?

Acupuncture is generally considered safe for breast cancer patients, with no serious adverse events reported in studies. Some mild side effects like bruising, pain, or swelling may occur. ^{1 2 4 5 6}

Is acupuncture a promising treatment for cognitive difficulties related to breast cancer?

Yes, acupuncture shows promise as a treatment for cognitive difficulties related to breast cancer. Studies suggest it can help manage symptoms like memory issues and emotional well-being, especially when other proven options are lacking. It has been shown to improve working memory and reduce symptoms like anxiety and poor appetite in breast cancer patients undergoing chemotherapy. ^{1 2 5 7 8}

How does acupuncture differ from other treatments for breast cancer-related cognitive difficulties?

Acupuncture is unique because it involves stimulating specific points on the body, often using needles, to potentially improve cognitive function and alleviate symptoms like anxiety and digestive issues, without the use of drugs. Unlike standard treatments, acupuncture offers a non-drug approach that may help manage cognitive difficulties related to chemotherapy, with evidence suggesting benefits for psychological and neurological symptoms. ^{1 2 5 7 8}

Research Team

Jun Mao, MD, MSCE

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

References

1. Netherlands 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. [2021]

2. United States 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. [2019]

3. United States 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. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Acupuncture Improves Multiple Treatment-Related Symptoms in Breast Cancer Survivors: A Systematic Review and Meta-Analysis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Acupuncture for chemotherapy-associated cognitive dysfunction: a hypothesis-generating literature review to inform clinical advice. [2007]

6. Germany pubmed.ncbi.nlm.nih.gov

Breast cancer survivors willingness to participate in an acupuncture clinical trial: a qualitative study. [2022]

7. China pubmed.ncbi.nlm.nih.gov

[The theoretical basis and acupoint selection of acupuncture treatment for "chemo brain"]. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Attention Dysregulation in Breast Cancer Patients Following a Complementary Alternative Treatment Routine: A Double-Blind Randomized Trial. [2021]