Acupressure for Breast Cancer

Overseen By Cancer AnswerLine

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan Rogel Cancer Center

Must be taking: Aromatase inhibitors

Must not be taking: Estrogen

Disqualifiers: Acupuncture, Surgery, Arthritis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether acupressure, a technique applying pressure on specific body points, can relieve joint pain and stiffness in postmenopausal women with breast cancer experiencing side effects from aromatase inhibitor (AI) therapy. Researchers aim to determine if acupressure can ease these musculoskeletal symptoms and explore its effect on gut health. The trial seeks participants who have been on AI therapy for breast cancer for at least three weeks and are experiencing new or worsening joint pain since starting the medication. As an unphased trial, this study offers participants the opportunity to explore a non-drug approach to managing their symptoms.

Will I have to stop taking my current medications?

You can continue taking your current medications if they are stable for at least 30 days before joining the study. If you plan to stop any medication, you should do so at least 7 days before starting the study treatment.

What prior data suggests that acupressure is safe for postmenopausal women with breast cancer?

Research shows that acupressure, similar to acupuncture but using finger pressure instead of needles, is generally safe. Studies on acupuncture, which resembles acupressure, suggest it is well-tolerated when performed by trained professionals. Since acupressure doesn't involve needles, it further reduces the risk of side effects.

Although acupuncture has been used to help manage symptoms in cancer patients without major safety concerns, specific information on acupressure's safety for breast cancer patients remains limited. However, because it is non-invasive and similar treatments like acupuncture are safe, acupressure is expected to be safe for most people. Always consult a healthcare provider before starting any new treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using acupressure for breast cancer patients because it offers a non-invasive and natural approach to managing symptoms. Unlike standard treatments like chemotherapy and radiation, which often have significant side effects, acupressure focuses on stimulating specific points on the body to promote relaxation and potentially alleviate discomfort. The AcuWand used in this approach allows for precise targeting of acupoints, ensuring consistent and effective stimulation. This method could provide a complementary option for patients seeking alternative ways to improve their quality of life during treatment.

What evidence suggests that acupressure might be an effective treatment for AI-associated musculoskeletal symptoms in breast cancer patients?

Studies have shown that acupressure can reduce symptoms like tiredness, improve sleep, and enhance the quality of life for cancer patients. Research indicates that 90% of patients using both acupressure and acupuncture experienced significant benefits. In this trial, participants will join one of two acupressure groups to evaluate its effectiveness. Additionally, acupressure effectively reduces pain and other side effects of cancer treatments, such as hot flashes and fatigue. These findings suggest that acupressure might be a promising option to ease joint pain and stiffness for those taking aromatase inhibitors for breast cancer. ^{1 6 7 8 9}

Who Is on the Research Team?

Norah L. Henry

Principal Investigator

University of Michigan Rogel Cancer Center

Are You a Good Fit for This Trial?

This trial is for postmenopausal women and men over 18 with breast cancer who've completed surgery and possibly chemotherapy. They must be experiencing new or worsening joint pain from aromatase inhibitor therapy, have stable internet access, and agree to use the same AI therapy for at least 12 weeks. Exclusions include recent acupressure/acupuncture users, estrogen users during the study, those planning surgeries within the study period, or having concurrent conditions that could affect pain assessment.

Inclusion Criteria

Able to self-complete questionnaires in English

I plan to continue my current AI therapy for at least 12 weeks.

Able to access WiFi/internet and willing to use an email account or download and use the MyDataHelps app

Exclusion Criteria

I do not have painful bone conditions that could affect pain assessment, except for osteoarthritis or symptom-free bone metastases.

Patients with a prior or concurrent malignancy whose natural history or treatment, in the opinion of the treating investigator, has the potential to interfere with the safety or efficacy assessment of the investigational regimen

I have used or plan to use acupuncture or acupressure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants perform self-acupressure daily to examine the effect on AI-associated musculoskeletal symptoms

12 weeks

Daily self-administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Acupressure

Trial Overview The trial tests self-acupressure's effectiveness on musculoskeletal symptoms caused by aromatase inhibitors in breast cancer patients. It's a randomized, double-blinded study where participants apply pressure to specific body points themselves to relieve joint pain and stiffness. The impact on other symptoms and changes in gut microbiome due to acupressure are also being explored.

How Is the Trial Designed?

Group I: Acupressure Arm 2 Experimental Treatment 1 Intervention

There are 5 acupoints with 4 of the acupoints performed on both the left and right sides of the body. Each of the 9 acupoints will be stimulated for 3 minutes per point giving a total treatment time of 27 minutes daily. The acupoints are unlisted in order to maintain blinding.

Group II: Acupressure Arm 1 Experimental Treatment 1 Intervention

There are 5 acupoints with 4 of the acupoints performed on both the left and right sides of the body. Each of the 9 acupoints will be stimulated for 3 minutes per point with the AcuWand giving a total treatment time of 27 minutes daily. The relaxation acupoints are unlisted in order to maintain blinding.

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

Approved in United States as Acupressure for:

• Relief from aromatase inhibitor-associated musculoskeletal symptoms in breast cancer patients

Approved in European Union as Acupressure for:

• Complementary therapy for symptom management in cancer patients, including relief from aromatase inhibitor-associated musculoskeletal symptoms

Who Is Running the Clinical Trial?

University of Michigan Rogel Cancer Center

Lead Sponsor

Trials

303

Recruited

20,700+

Breast Cancer Research Foundation

Collaborator

Trials

79

Recruited

40,500+

Published Research Related to This Trial

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]

A meta-analysis of 16 randomized clinical trials involving 1019 cancer patients showed that acupuncture and acupressure had a total effective rate of 90% in treating cancer-related depression, compared to 72.5% for those receiving antidepressants.

The study supports the use of acupuncture and acupressure as effective non-pharmacological treatments for cancer-related depression, potentially reducing reliance on medications and their associated side effects, while improving patients' quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture and acupressure with improved cancer-related depression of retrospective studies. Wang, F., Zhao, J., Li, Y., et al.[2023]

Acupressure applied to the P6 acupuncture point significantly reduced nausea, vomiting, and anxiety in 64 breast cancer patients undergoing chemotherapy, demonstrating its efficacy as a supportive treatment.

Patients receiving acupressure had lower scores for nausea, vomiting, and anxiety compared to a control group, indicating that this non-invasive intervention can help alleviate common side effects of chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of acupressure application on chemotherapy-induced nausea, vomiting, and anxiety in patients with breast cancer. Genç, F., Tan, M.[2022]

In a study of 45 women with a history of breast cancer, electro-acupuncture (EA) significantly reduced the median number of hot flushes from 9.6 to 4.3 per day after 12 weeks of treatment, with lasting effects observed up to 24 months.

Hormone therapy (HT) also effectively eliminated hot flushes, reducing them from a median of 6.6 to 0.0 per day at 12 weeks, indicating that both EA and HT are viable options for managing vasomotor symptoms in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term follow-up of acupuncture and hormone therapy on hot flushes in women with breast cancer: a prospective, randomized, controlled multicenter trial. Frisk, J., Carlhäll, S., Källström, AC., et al.[2008]

Acupoint stimulation, particularly acupressure on the P6 acupoint, has shown positive effects in managing chemotherapy-induced nausea and vomiting in breast cancer patients, with 88% of the 26 trials reviewed reporting beneficial outcomes.

However, only 35% of the trials were of high quality, indicating a need for more rigorously designed studies to confirm the efficacy of acupoint stimulation for other therapy-related adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of acupoint stimulation for the management of therapy-related adverse events in patients with breast cancer: a systematic review. Chao, LF., Zhang, AL., Liu, HE., et al.[2022]

In a study of 48 women recovering from breast cancer surgery, both acupuncture combined with kinesiotherapy and kinesiotherapy alone significantly improved pain, upper limb function, and range of motion after 10 treatment sessions.

While both treatment groups showed improvements, there were no significant differences in outcomes between the two groups, indicating that kinesiotherapy alone may be as effective as adding acupuncture for rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of acupuncture in rehabilitation of physical and functional disorders of women undergoing breast cancer surgery. Giron, PS., Haddad, CA., Lopes de Almeida Rizzi, SK., et al.[2018]

A 54-year-old woman with metastatic breast cancer and severe lower back pain found significant relief from her pain after just two acupuncture treatments, highlighting acupuncture's potential efficacy in managing chronic pain when other treatments fail.

While acupuncture was effective for her back pain, it did not provide relief for neuropathic pain related to her mastectomy scar, indicating that acupuncture may not be universally effective for all types of pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 54-year-old woman with degenerative back pain. Tuck, CM.[2010]

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]

Auricular point acupressure (APA) significantly improved sleep quality in women with breast cancer undergoing chemotherapy, as evidenced by decreased Pittsburgh Sleep Quality Index (PSQI) scores and improved sleep metrics after three weeks of treatment.

The study involved 68 participants and demonstrated that APA is a potentially effective and low-cost intervention for enhancing sleep quality, although further research with a larger sample size is needed to confirm these results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptive Auricular Point Acupressure for Sleep Disturbance in Women with Breast Cancer: A Randomized Controlled Trial. Wang, Y., Li, X., Ji, X., et al.[2022]

Auricular acupressure significantly improves sleep quality in cancer patients, as evidenced by a reduction in the Pittsburgh Sleep Quality Index (PSQI) score, with a mean difference of -3.88, based on a meta-analysis of 6 trials involving 485 participants.

The intervention showed no serious side effects, with only one trial reporting slight and transient pain, indicating that auricular acupressure is a safe option for managing sleep disturbances in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auricular Acupressure Therapy for Patients with Cancer with Sleep Disturbance: A Systematic Review and Meta-Analysis. Wang, Y., Zhang, J., Jin, Y., et al.[2022]

Auricular acupressure significantly improved the quality of life for women with breast cancer undergoing chemotherapy, particularly in reducing nausea, vomiting, and breast symptoms, based on a randomized trial with 54 participants over 12 weeks.

The intervention was found to be safe, effective, low-cost, and easy to apply by trained nurses, suggesting it could be a valuable complementary therapy for enhancing the well-being of breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auricular acupressure in the quality of life of women with breast cancer: a randomized clinical trial. Vallim, ETA., Marques, ADCB., Coelho, RCFP., et al.[2022]

In a study of 60 breast cancer patients, the combined therapy of acupuncture and auricular acupressure showed a significantly higher total effective rate of 86.7% compared to 63.3% for fluoxetine, indicating superior efficacy in treating depression.

The acupuncture and acupressure treatment not only reduced depression scores more effectively but also resulted in fewer side effects, demonstrating a safer alternative to traditional medication like fluoxetine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficacy on depression in breast cancer treated with acupuncture and auricular acupressure]. Xiao, B., Liu, ZH.[2014]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11753630/

Self-acupressure for patients with breast cancer experiencing ... Aromatase inhibitors (AI) reduce hormone receptor-positive breast cancer recurrence risk by about 50%. However, half of AI-treated ...

2. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2532352

Investigation of 2 Types of Self-administered Acupressure ... Improvements in fatigue, sleep, and quality of life were sustained for 4 weeks after cessation of acupressure. Self-administered relaxing ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9791202/

Acupuncture and acupressure with improved cancer ... Three hundred sixty-one patients underwent acupuncture and acupressure; the total effective rate was 90%. Meta-analysis results showed I2 = 0%, no heterogeneity ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05510700?term=AREA%5BBasicSearch%5D(Acupuncture%20treatment%20AND%20cancer%20AND%20point)&rank=10

Efficacy of Acupuncture Treatment for Breast Cancer ... The purpose of this study was to evaluate the clinical efficacy and safety of acupuncture for breast cancer-associated insomnia. Official Title. Acupuncture for ...

5. facingourrisk.org facingourrisk.org/XRAY/acupuncture-for-breast-cancer-treatment-side-effects

Acupuncture may ease breast cancer treatment side effects In this analysis, acupuncture was more effective than untreated groups in reducing the intensity of pain, the severity of hot flashes and fatigue. They then ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10940387/

Acupuncture in cancer care: recommendations for safe ... Numerous studies report that acupuncture is a safe intervention when performed by qualified practitioners, and in the general population adverse ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S096522992400075X

Efficacy and safety of acupuncture for the treatment ... Acupuncture can partially alleviate insomnia symptoms in breast cancer patients. Moreover, acupuncture is safe and may serve as a dependable alternative therapy ...

8. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.34165

Safety of acupuncture in oncology: A systematic review and ... Acupuncture is frequently used to treat the side effects of cancer treatment, but the safety of this intervention remains uncertain.

9. integrmed.org integrmed.org/journal/view.php?number=37

Acupuncture Needles and the Risk of Lymphedema After ... We observed that acupuncture, initiated between 3 to 6 months post-surgery did not affect BCRL risk, a conclusion supported by sensitivity ...