Acupuncture for Breast Cancer-Related Cognitive Difficulties
Recruiting in Palo Alto (17 mi)
+7 other locations
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Memorial Sloan Kettering Cancer Center
Prior Safety Data
Approved in 4 Jurisdictions
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.
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.12345
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.12456
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.12578
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.
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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.
See 11 more
Treatment Details
Interventions
- Acupuncture (Behavioural Intervention)
- Sham Acupuncture (Behavioural Intervention)
Trial OverviewThe 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
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.
Acupuncture is already approved in United States, European Union, China, Australia 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
🇦🇺 Approved in Australia as Acupuncture for:
- Pain management
- Hot flashes
- Fatigue
- Sleep disturbances
- Anxiety
- Depression
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Memoral Sloan Kettering Westchester (Limited Protocol Activities)Harrison, NY
Memorial Sloan Kettering Basking Ridge (Limited Protocol activities)Basking Ridge, NJ
Memorial Sloan Kettering Monmouth (Limited Protocol activities)Middletown, NJ
Memorial Sloan Kettering Bergen (Limited Protocol Activities)Montvale, NJ
More Trial Locations
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Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
References
Electroacupuncture trigeminal nerve stimulation plus body acupuncture for chemotherapy-induced cognitive impairment in breast cancer patients: An assessor-participant blinded, randomized controlled trial. [2021]Chemotherapy causes various side effects, including cognitive impairment, known as 'chemobrain'. In this study, we determined whether a novel acupuncture mode called electroacupuncture trigeminal nerve stimulation plus body acupuncture (EA/TNS + BA) could produce better outcomes than minimum acupuncture stimulation (MAS) as controls in treating chemobrain and other symptoms in breast cancer patients. In this assessor- and participant-blinded, randomized controlled trial, 93 breast cancer patients under or post chemotherapy were randomly assigned to EA/TNS + BA (n = 46) and MAS (n = 47) for 2 sessions per week over 8 weeks. The Montreal Cognitive Assessment (MoCA) served as the primary outcome. Digit span test was the secondary outcomes for attentional function and working memory. The quality of life and multiple functional assessments were also evaluated. EA/TNS + BA treated group had much better performance than MAS-treated group on reverse digit span test at Week 2 and Week 8, with medium effect sizes of 0.53 and 0.48, respectively, although no significant differences were observed in MoCA score and prevalence of chemobrain between the two groups. EA/TNS + BA also markedly reduced incidences of diarrhoea, poor appetite, headache, anxiety, and irritation, and improved social/family and emotional wellbeing compared to MAS. These results suggest that EA/TNS + BA may have particular benefits in reducing chemotherapy-induced working memory impairment and the incidence of certain digestive, neurological, and distress-related symptoms. It could serve as an effective intervention for breast cancer patients under and post chemotherapy (trial registration: https://www.clinicaltrials.gov: NCT02457039).
Clinical Benefits of Acupuncture for the Reduction of Hormone Therapy-Related Side Effects in Breast Cancer Patients: A Systematic Review. [2019]Acupuncture can help reduce unpleasant side effects associated with endocrine therapy for breast cancer. Nevertheless, comprehensive evaluation of current evidence from randomized controlled trials(RCTs) is lacking.
Acupuncture for Hormone Therapy-Related Side Effects in Breast Cancer Patients: A GRADE-Assessed Systematic Review and Updated Meta-Analysis. [2022]Purpose: To determine the efficacy of acupuncture on the management of hormone therapy-related side effects in breast cancer patients. Methods: Randomized controlled trials of acupuncture versus a control or placebo in breast cancer patients that examined reductions in therapy-related side effects were retrieved from PubMed, EMBASE, Web of Science, and the Cochrane Library through April 2020. Data on patient symptoms (hot flashes, fatigue, pain, stiffness, and gastrointestinal symptoms), physical capacity, cytokines, and general psychosomatic well-being were analyzed. We evaluated and analyzed the quality of all included studies with the 5.2 Cochrane Handbook standards using Stata software (version 10.0) and Revman software (version 5.2), respectively. We assessed the risk of bias using the Cochrane Risk of Bias tool and evaluated the quality of evidence using the GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) approach. Results: The pooled results suggested that acupuncture led to moderate improvements in hot flashes, fatigue, and stiffness. No significant differences were observed in pain, gastrointestinal symptoms, Kupperman index scores, Overall quality of life, tumor necrosis factor levels, and interleukin levels. Conclusions: Evidence for outcome indicators of symptom management were downgraded by the GRADE system for inconsistency, indirectness, and imprecision in the included RCTs. Nonetheless, acupuncture is a moderately appropriate alternative therapy for hormone therapy-related side effects in breast cancer patients. However, it still lacks large-sample, multicenter, prospective RCTs. Future research should focus on standardizing comparison groups and treatment methods, be at least single-blinded, assess biologic mechanisms, have adequate statistical power, and involve multiple acupuncturists.
Acupuncture Improves Multiple Treatment-Related Symptoms in Breast Cancer Survivors: A Systematic Review and Meta-Analysis. [2022]Introduction: Acupuncture has demonstrated effectiveness for symptom management among breast cancer survivors. This meta-analysis aims to evaluate the effect of acupuncture on treatment-related symptoms among breast cancer survivors. Methods: The authors searched PubMed, CINAHL, and EMBASE for relevant randomized clinical trials (RCTs) of acupuncture for managing treatment-related symptoms published in English through June 2021. They appraised the quality of each article using the Cochrane Collaboration Risk of Bias Criteria. The primary outcomes were pain, hot flashes, sleep disturbance, fatigue, depression, lymphedema, and neuropathy as individual symptoms. They also evaluated adverse events reported in acupuncture studies. Results: Of 26 selected trials (2055 patients), 20 (1709 patients) were included in the meta-analysis. Acupuncture was more effective than control groups in improving pain intensity [standardized mean difference (SMD) = -0.60, 95% confidence intervals (CI) -1.06 to -0.15], fatigue [SMD = -0.62, 95% CI -1.03 to -0.20], and hot flash severity [SMD = -0.52, 95% CI -0.82 to -0.22]. The subgroup analysis indicated that acupuncture showed trends but not significant effects on all the treatment-related symptoms compared with the sham acupuncture groups. Compared with waitlist control and usual care groups, the acupuncture groups showed significant reductions in pain intensity, fatigue, depression, hot flash severity, and neuropathy. No serious adverse events were reported related to acupuncture intervention. Mild adverse events (i.e., bruising, pain, swelling, skin infection, hematoma, headache, menstrual bleeding) were reported in 11 studies. Conclusion: This systematic review and meta-analysis suggest that acupuncture significantly reduces multiple treatment-related symptoms compared with the usual care or waitlist control group among breast cancer survivors. The safety of acupuncture was inadequately reported in the included studies. Based on the available data, acupuncture seems to be generally a safe treatment with some mild adverse events. These findings provide evidence-based recommendations for incorporating acupuncture into clinical breast cancer symptom management. Due to the high risk of bias and blinding issues in some RCTs, more rigorous trials are needed to confirm the efficacy of acupuncture in reducing multiple treatment-related symptoms among breast cancer survivors.
Acupuncture for chemotherapy-associated cognitive dysfunction: a hypothesis-generating literature review to inform clinical advice. [2007]There is an emerging consensus that between one fifth and one half of breast cancer patients experience chemotherapy-associated cognitive dysfunction. Research shows that patients with cancer are often interested in acupuncture for symptom relief. A clinical question thus arises: What should physicians advise their patients regarding the use of acupuncture to alleviate or ameliorate chemotherapy-associated cognitive dysfunction? The authors review and synthesize 2 bodies of relevant research literature: (1) the developing literature on the etiology and nature of chemotherapy-associated cognitive dysfunction and (2) the literature concerning acupuncture for neurological diseases and psychological issues. There is evidence that acupuncture may be effectively used to manage a range of psychoneurological issues, some of which are similar to those experienced by patients with chemotherapy-associated cognitive dysfunction. The evidence of efficacy is more promising for psychological than neurological conditions. Given evidence of possible efficacy combined with evidence of demonstrated safety, we suggest that physicians should support patient decisions to use acupuncture services for chemotherapy-associated cognitive dysfunction, especially given the lack of proven alternatives.
Breast cancer survivors willingness to participate in an acupuncture clinical trial: a qualitative study. [2022]Acupuncture is a complementary and alternative medicine (CAM) modality that shows promise as a component of supportive breast cancer care. Lack of robust recruitment for clinical trial entry has limited the evidence base for acupuncture as a treatment modality among breast cancer survivors. The objective of this study is to identify key decision-making factors among breast cancer survivors considering entry into an acupuncture clinical trial for treatment of symptoms.
[The theoretical basis and acupoint selection of acupuncture treatment for "chemo brain"]. [2019]Through clinical practice and literature analysis, the effectiveness and feasibility of acupuncture and moxibustion for "chemo brain" (chemotherapy-induced cognitive impairment, CICI) are explored, which provides a theoretical basis of acupuncture and moxibustion for "chemotherapy brain". From the point view of TCM, CICI is classified as amnesia-like disease. The location of disease is in brain and it is most closely related to heart and kidney. The pathogenesis is the deficiency of kidney and marrow, often accompanied with stagnation of qi due to depression of liver. It is deficient in root and excessive in superficial. From the point view of modern research, CICI is a cognitive dysfunction disease, which is closely related to the cerebral cortex and hippocampus. Acupuncture can play a neuroprotective role by regulating various mechanisms to improve cognitive dysfunction. The acupuncture prescriptions should focus on regulating liver and nourishing kidney, accompanied with head acupoints to improve brain and intelligence. The electroacupuncture can be applied. Acupuncture has a rich theoretical basis in the treatment of CICI, but there is a lack of research in this area.
Attention Dysregulation in Breast Cancer Patients Following a Complementary Alternative Treatment Routine: A Double-Blind Randomized Trial. [2021]Breast cancer patients and survivors frequently report fatigue, emotional, and cognitive disturbances, which reduce performance at all levels of occupation and make life quality issues a considerable clinical concern. The aim of this study is to evaluate attention and emotion regulation across radiotherapy period and the possible effects of complementary alternative medicine (CAM).