An interventional study of Acupuncture in Breast Cancer and Stiffness of Hand, Not Elsewhere Classified, sponsored by Affiliated Hospital of Qinghai University. Status unknown at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-11-10.
Sponsored by Affiliated Hospital of Qinghai University · Not applicable, Interventional, and Supportive care
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.
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.
12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 52 is below the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Affiliated Hospital of Qinghai University is the lead sponsor of 17 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This is a single arm study. All the enrolled patients will receive acupuncture twice weekly for 6 weeks then once weekly for another 6 weeks.
Device: Acupuncture
Patients with stiffness of joint receive acupuncture therapy twice weekly for 6 weeks and then once weekly for 6 weeks.
The change in stiffness score as measured by the Western Ontario and McMasters Universities Osteoarthritis (WOMAC)
The change in stiffness score as measured by the Western Ontario and McMasters Universities Osteoarthritis (WOMAC) at the end of week 6 of intervention compared to that at baseline.
Time frame: 6 weeks
The change in stiffness score as measured by the Modified Score for the Assessment of Chronic Rheumatoid Affections of the Hands (M-SACRAH)
The change in stiffness score as measured by the Modified Score for the Assessment of Chronic Rheumatoid Affections of the Hands (M-SACRAH) at the end of week 6 of intervention compared to that at baseline.
Time frame: 6 weeks
This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Affiliated Hospital of Qinghai University