NCT05098951

Acupuncture for Stiffness of Joint Related to Aromatase Inhibitors in Patients With Early-Stage Breast Cancer

Efficacy and Safety of Acupuncture for Relieving Stiffness of Joint Related to Aromatase Inhibitors in Patients With Early-Stage Breast Cancer

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Affiliated Hospital of Qinghai University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Acupuncture may help relieve joint stiffness related to aromatase inhibitors in patients with early-stage breast cancer. PURPOSE: This single arm clinical study aims to evaluate how well acupuncture as a non-pharmacological treatment, works in treating patients with joint stiffness related to aromatase inhibitors (AIs) in patients with early-stage breast cancer.

Detailed description

Objectives of this study: Primary objective: To evaluate whether acupuncture as a non-pharmacological treatment, administered twice weekly for 6 weeks can significantly reduce joint stiffness related to AIs in women with early-stage breast cancer as measured by the Western Ontario and McMasters Universities Osteoarthritis (WOMAC) stiffness score at weeks 6. Secondary objectives: To evaluate the effect of acupuncture on joint stiffness measured by the WOMAC stiffness score at weeks 12. To evaluate the effect of acupuncture on joint stiffness measured by the Modified Score for the Assessment of Chronic Rheumatoid Affections of the Hands (M-SACRAH) stiffness score at weeks 6 and weeks 12. To evaluate the effects of acupuncture on quality of life (QOL) assessed by the Functional Assessment of Cancer Therapy-Endocrine Subscales (FACT-ES) at weeks 6 and weeks 12. To evaluate the safety and tolerability of acupuncture in the enrolled patients. To identify potential genetic determinants to response to acupuncture.

Conditions

• Breast Cancer
• Stiffness of Hand, Not Elsewhere Classified

Interventions

Type	Name	Description
DEVICE	Acupuncture	Patients with stiffness of joint receive acupuncture therapy twice weekly for 6 weeks and then once weekly for 6 weeks.

Timeline

• Start date: 2021-10-20
• Primary completion: 2022-09-01
• Completion: 2023-06-01
• First posted: 2021-10-29
• Last updated: 2021-11-10

Locations

1 site across 1 country: China