Acupuncture for Stiffness of Joint Related to Aromatase Inhibitors in Patients With Early-Stage Breast Cancer
NCT ID: NCT05098951
Last Updated: 2021-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
52 participants
INTERVENTIONAL
2021-10-20
2023-06-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients with stiffness of joint receive acupuncture therapy
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.
Acupuncture
Patients with stiffness of joint receive acupuncture therapy twice weekly for 6 weeks and then once weekly for 6 weeks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Acupuncture
Patients with stiffness of joint receive acupuncture therapy twice weekly for 6 weeks and then once weekly for 6 weeks.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Postmenopausal or premenopausal with ovarian suppression
3. Currently receiving aromatase inhibitors (Anastrozole, Letrozole, or Exemestane) treatment
4. With joint stiffness attributed to the use of aromatase inhibitors
5. Having had joint stiffness for at least 1 months
6. Having had at least 15 days with stiffness in the preceding 30 days
Exclusion Criteria
2. Women having finished chemotherapy or radiation therapy less than 1 months prior to enrollment
3. Women with history of bleeding disorder
4. Women with joint stiffness attributed to inflammatory arthritis, such as rheumatoid arthritis, spondy loarthritis and osteoarthritis
5. Women having joint stiffness prior to AI treatment
6. Women that have received treatment of any kind for joint stiffness within the last 3 months
7. Women that have previously received the acupuncture treatment before for any reason
18 Years
75 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Affiliated Hospital of Qinghai University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jiuda Zhao
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jiuda Zhao
Role: PRINCIPAL_INVESTIGATOR
the Affiliated Hospital of Qinghai University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Affiliated Hospital of Qinghai University, Affiliated Cancer Hospital of Qinghai University
Xining, Qinghai, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Dengfeng Ren
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AHQU-2021004
Identifier Type: -
Identifier Source: org_study_id