Acupressure for Breast Cancer

Recruiting in Ann Arbor (>99 mi)

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

50 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Acupressure for Breast Cancer?

Research shows that acupressure, a form of acupuncture without needles, can help manage chemotherapy-related nausea and improve sleep quality in women with breast cancer. Studies have found positive outcomes in using acupressure for these specific issues, although more high-quality research is needed to confirm these benefits. ^{1 2 3 4 5}

Is acupressure safe for breast cancer patients?

Acupressure is generally considered safe for breast cancer patients, with very few minor side effects reported in studies. It has been used to help manage symptoms like nausea and sleep disturbances, and is recognized as safe by the international medical community. ^{3 6 7 8 9}

How does the acupressure treatment for breast cancer differ from other treatments?

Acupressure for breast cancer is unique because it involves applying pressure to specific points on the body, like the P6 acupoint, to help manage symptoms such as chemotherapy-induced nausea and vomiting, without using needles or drugs. This non-invasive approach is different from traditional treatments that often involve medication or surgery. ^{3 5 10 11 12}

What is the purpose of this trial?

This is a randomized, double-blinded trial of self-acupressure to examine the effect of treatment on aromatase inhibitor (AI)-associated musculoskeletal symptoms (AIMSS) in postmenopausal women with breast cancer. Acupressure is similar to acupuncture, but uses pressure rather than needles to stimulate specific points on the body. Acupressure involves applying mild to moderate physical pressure using your fingers, or an assistive device, to these points to try to bring about a physiological change in your body, in this case relief from joint pain and stiffness. The investigators will also examine effects of acupressure on other symptoms that commonly develop in AI-treated patients. In addition, changes in stool microbiome with acupressure treatment will be examined in an exploratory way to obtain preliminary information about the effect of acupressure on the gut microbiome in this condition.

Research Team

Norah L. Henry

Principal Investigator

University of Michigan Rogel Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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 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]

References

1. Brazil pubmed.ncbi.nlm.nih.gov

Auricular acupressure in the quality of life of women with breast cancer: a randomized clinical trial. [2022]

2. China pubmed.ncbi.nlm.nih.gov

[Efficacy on depression in breast cancer treated with acupuncture and auricular acupressure]. [2014]

3. Netherlands 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. [2022]

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

Adaptive Auricular Point Acupressure for Sleep Disturbance in Women with Breast Cancer: A Randomized Controlled Trial. [2022]

5. England 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. [2008]

6. 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]

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

Auricular Acupressure Therapy for Patients with Cancer with Sleep Disturbance: A Systematic Review and Meta-Analysis. [2022]

8. 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]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Acupuncture and acupressure with improved cancer-related depression of retrospective studies. [2023]

10. England pubmed.ncbi.nlm.nih.gov

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

11. Germany pubmed.ncbi.nlm.nih.gov

Effectiveness of acupuncture in rehabilitation of physical and functional disorders of women undergoing breast cancer surgery. [2018]

12. England pubmed.ncbi.nlm.nih.gov

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