Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06534125
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Acutherapy to Prevent Aromatase Inhibitor-Associated Arthralgias in Non-Hispanic Black Postmenopausal Women with Early-Stage Breast Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Preventing Aromatase Inhibitor-Associated Arthralgias Among Non-Hispanic Black Postmenopausal Women with Early-Stage Breast Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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-positivehuman 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
III To evaluate the acceptance satisfaction convenience accessibility and perceptions of in-person acupuncture and virtual acupressure
IV To conduct 4 focus groups of 6-12 non-Hispanic Black women who receive 12 weeks of acupuncture or acupressure and collect and analyze qualitative data about barriers and facilitators to completing each intervention transportation concerns and ease or difficulty of completing each intervention
OUTLINE Patients are randomized to 1 of 3 arms
ARM I 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 AI therapy
ARM II 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
ARM III Patients receive SOC AI therapy
After completion of study intervention patients are followed up for 12 months or until the initiation of new antineoplastic or investigational therapy whichever occurs first
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-positivehuman 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
III To evaluate the acceptance satisfaction convenience accessibility and perceptions of in-person acupuncture and virtual acupressure
IV To conduct 4 focus groups of 6-12 non-Hispanic Black women who receive 12 weeks of acupuncture or acupressure and collect and analyze qualitative data about barriers and facilitators to completing each intervention transportation concerns and ease or difficulty of completing each intervention
OUTLINE Patients are randomized to 1 of 3 arms
ARM I 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 AI therapy
ARM II 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
ARM III Patients receive SOC AI therapy
After completion of study intervention patients are followed up for 12 months or until the initiation of new antineoplastic or investigational therapy whichever occurs first
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None