Preventing Aromatase Inhibitor-Associated Arthralgias Among Non-Hispanic Black Postmenopausal Women With Early-Stage Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- Brief pain inventory (BPI) pain severity score
研究概览
简要总结
This clinical trial evaluates if in-person acupuncture or virtual acupressure therapy prevents aromatase inhibitor-associated joint pain in Non-Hispanic Black postmenopausal women with stage I-III (early-stage) hormone receptor positive (HR+) breast cancer. Aromatase inhibitors (AI) are medications that prevent the formation of the hormone estrogen. They are used in the treatment of postmenopausal women who have hormone-dependent breast cancer. AI therapy prolongs life among patients with early-stage HR+ breast cancer. Many postmenopausal women stop AI therapy early due to debilitating joint pain (arthralgias). Non-Hispanic Black women are more likely to experience side effects and stop their hormonal therapy compared to Non-Hispanic white women. Acupuncture therapy involves inserting thin needles through the skin at specific points on the body to control pain. Acupressure therapy uses the application of pressure or localized massage to specific sites on the body to control symptoms such as pain. Acupuncture and acupressure are types of complementary and alternative medicine. Undergoing in-person acupuncture or participating in virtual acupressure may prevent AI-associated arthralgias (AIAA) in Non-Hispanic Black postmenopausal women with early-stage HR+ breast cancer.
详细描述
PRIMARY OBJECTIVE:
I. To determine if initiation of in-person acupuncture or virtual acupressure sessions within 2 weeks of starting aromatase inhibitors (AI) will reduce the severity and incidence of AI-associated arthralgias (AIAA) among non-Hispanic Black postmenopausal women with stage I-III hormone receptor-positive/human epidermal growth factor receptor 2 (HER2)-negative breast cancer at 6 months after starting adjuvant AI therapy.
SECONDARY OBJECTIVES:
I. To compare the efficacy of acupuncture to the efficacy of acupressure among the study population.
II. To determine if acupuncture or acupressure will increase AI adherence (secondary endpoint) among the study population at 6 months after starting adjuvant AI therapy.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Self-identified Non-Hispanic Black woman
- •Postmenopausal status (>= 12 months since last menstrual period, history of bilateral salpingo-oophorectomy, or estradiol, follicle-stimulating hormone [FSH], and luteinizing hormone [LH] levels consistent with menopause)
- •Diagnosed with stage I-III HR+/HER2 negative (-) breast cancer
- •Completed all phases of active therapy (e.g. surgery, chemotherapy, and/or radiation) at least 14 days before study enrollment
- •Planned to start adjuvant AI
排除标准
- •Diagnosed with metastatic breast cancer
- •Premenopausal status
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to acupuncture needles or other agents used in study
- •Diagnosis of rheumatoid arthritis, multiple sclerosis, or muscular dystrophy
- •A history of or current CDK 4/6 inhibitor use
- •A history of neoadjuvant AI use
- •Use of adjuvant AI > 14 days
- •Received acupuncture within 60 days prior to start of study
研究组 & 干预措施
Arm I (acupuncture, AI therapy)
Patients undergo acupuncture therapy in-person over 1 hour twice weekly for the first 6 weeks and then once weekly for 6 weeks and receive standard of care (SOC) aromatase inhibitor (AI) therapy.
干预措施: Acupuncture Therapy (Device)
Arm I (acupuncture, AI therapy)
Patients undergo acupuncture therapy in-person over 1 hour twice weekly for the first 6 weeks and then once weekly for 6 weeks and receive standard of care (SOC) aromatase inhibitor (AI) therapy.
干预措施: Aromatase Inhibition Therapy (Drug)
Arm I (acupuncture, AI therapy)
Patients undergo acupuncture therapy in-person over 1 hour twice weekly for the first 6 weeks and then once weekly for 6 weeks and receive standard of care (SOC) aromatase inhibitor (AI) therapy.
干预措施: Discussion (Other)
Arm I (acupuncture, AI therapy)
Patients undergo acupuncture therapy in-person over 1 hour twice weekly for the first 6 weeks and then once weekly for 6 weeks and receive standard of care (SOC) aromatase inhibitor (AI) therapy.
干预措施: Survey Administration (Other)
Arm II (acupressure, AI therapy)
Patients undergo self-administered acupressure therapy virtually over 1 hour twice weekly for the first 6 weeks and then once weekly for 6 weeks and receive SOC AI therapy.
干预措施: Acupressure Therapy (Procedure)
Arm II (acupressure, AI therapy)
Patients undergo self-administered acupressure therapy virtually over 1 hour twice weekly for the first 6 weeks and then once weekly for 6 weeks and receive SOC AI therapy.
干预措施: Aromatase Inhibition Therapy (Drug)
Arm II (acupressure, AI therapy)
Patients undergo self-administered acupressure therapy virtually over 1 hour twice weekly for the first 6 weeks and then once weekly for 6 weeks and receive SOC AI therapy.
干预措施: Discussion (Other)
Arm II (acupressure, AI therapy)
Patients undergo self-administered acupressure therapy virtually over 1 hour twice weekly for the first 6 weeks and then once weekly for 6 weeks and receive SOC AI therapy.
干预措施: Survey Administration (Other)
Arm III (AI therapy)
Patients receive SOC AI therapy.
干预措施: Aromatase Inhibition Therapy (Drug)
Arm III (AI therapy)
Patients receive SOC AI therapy.
干预措施: Survey Administration (Other)
结局指标
主要结局
Brief pain inventory (BPI) pain severity score
时间窗: Baseline to 6 months after aromatase inhibitor (AI) start
Pain will be assessed by the BPI-Short Form. Pain severity is rated from 0-10 with higher scores indicating worse pain. Will measure change in BPI severity score from baseline as an absolute value and a percentage. Will also measure pain as a dichotomous variable (increase in BPI score \>= 1 point versus (vs) \< 1 point increase in pain severity) in order to determine the incidence of aromatase inhibitor-associated arthralgias (AIAA) and compare the incidence between study arms at 24 weeks. Participants can also list all pain medications they are taking. Will verify this information in their medical records.
Incidence of arthralgias
时间窗: Baseline to 6 months after AI start
Pain will be assessed by the BPI-Short Form. Pain severity is rated from 0-10 with higher scores indicating worse pain. Will measure change in BPI score from baseline as an absolute value and a percentage. Will also measure pain as a dichotomous variable (increase in BPI score \>= 1 point vs \< 1 point increase in pain severity) in order to determine the incidence of AIAA and compare the incidence between study arms at 24 weeks. Participants can also list all pain medications they are taking. Will verify this information in their medical records.
次要结局
- AI adherence(Baseline to 6 months after starting study intervention)
- Participant satisfaction rate(At 6 months after starting study intervention)
- Perceived difficulty of completing study intervention(At 6 months after starting study intervention)
- Intervention completion rate(At 6 months after starting study intervention)
- Pain severity(Baseline to 6 months after starting study intervention)
- Incidence of arthralgias(Baseline to 6 months after starting study intervention)
- Symptom burden(Baseline to 6 months after starting study intervention)
研究者
Demetria J. Smith-Graziani
Principal Investigator
Emory University