NCT06228768已完成不适用
Acupressure for Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Patients With Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in joint pain
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Both clinicians and participants will be blinded to study arm.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male subject aged ≥ 18 years
- •Taking the currently prescribed aromatase inhibitor therapy (anastrozole, exemestane, or letrozole) for adjuvant or palliative treatment of breast cancer or for chemoprevention for at least 3 weeks and no more than 2 years at the time of enrollment.
- •Planning to take the same AI therapy for at least 12 weeks.
- •New or worsening joint pain and/or myalgias since starting the AI therapy, with worst pain score of at least 4 out of 10 on the BPI over the 7 days prior to enrollment.
- •Completion of radiation therapy, if given, for treatment of breast cancer.
- •Completion of chemotherapy, if given. Concurrent use of LHRHa therapy, anti-HER2 therapy, bisphosphonate therapy, PARP inhibitor therapy, and CDK4/6 inhibitor therapy is permitted.
- •Patients receiving treatment with NSAIDs, acetaminophen, opioids, duloxetine, cannabinoids, gabapentin, and/or pregabalin must have been taking a stable dose for at least 30 days prior to enrollment if they plan to continue the drug during study participation. If they do not plan to take the medication during study participation, they should stop the medication at least 7 days before initiation of study treatment.
- •Able to self-complete questionnaires in English.
- •Able to access WiFi/internet and willing to use an email account or download and use the MyDataHelps app.
- •Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
排除标准
- •Use of acupuncture or acupressure in the past year, or planned use of acupuncture during study participation.
- •Use of systemic or transdermal estrogen during study participation.
- •Planned surgery during the 12-week study period.
- •Concurrent medical or arthritis disease such as painful bone metastases or active rheumatoid arthritis or inflammatory arthritis that could confound or interfere with evaluation of pain or efficacy. Patients with osteoarthritis and asymptomatic bone metastases are eligible.
- •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.
结局指标
主要结局
Change in joint pain
时间窗: baseline and 12 weeks after intervention is started
Range 0-10 after 12 weeks of intervention. Brief Pain Inventory (BPI) questionnaire will be used for this assessment. Comparison of baseline and 12 week assessment.
次要结局
- Proportion of patients with at least a 2 point reduction in pain (worst)(baseline and 12 weeks after intervention is started)
- Proportion of patients with at least a 2 point reduction in pain (average)(baseline and 12 weeks after intervention is started)
- Change in reported sleep disturbance(baseline, 6 weeks and 12 weeks after intervention is started)
- Difference from baseline for pain interference(baseline, 6 weeks and 12 weeks after intervention is started)
- Change in reported fatigue(baseline, 6 weeks and 12 weeks after intervention is started)
- Change in reported physical function(baseline, 6 weeks and 12 weeks after intervention is started)
- Change in anxiety(baseline, 6 weeks and 12 weeks after intervention is started)
- Change in depression(baseline, 6 weeks and 12 weeks after intervention is started)
- Change in cognitive function(baseline, 6 weeks and 12 weeks after intervention is started)
- Adherence to trial intervention (number of days completed)(12 weeks after intervention is started)
- Adherence to trial intervention (number of minutes completed)(12 weeks after intervention is started)
- safety of the intervention through reported adverse events(12 weeks after intervention is started)
研究者
研究点 (2)
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