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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05098951
• Other study ID #: AHQU-2021004
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: November 2021
• Source: Affiliated Hospital of Qinghai University
• Contact: Dengfeng Ren
• Phone: +8613086297659
• Email: dengfeng1104[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: June 1, 2023
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. History of stage I-III breast cancer and free of disease by clinical examination

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:

1. Women with recurrent or metastatic breast cancer

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Stiffness of Hand, Not Elsewhere Classified

Intervention

Device:
• Acupuncture
Patients with stiffness of joint receive acupuncture therapy twice weekly for 6 weeks and then once weekly for 6 weeks.

Locations

Country	Name	City	State
China	Affiliated Hospital of Qinghai University, Affiliated Cancer Hospital of Qinghai University	Xining	Qinghai

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital of Qinghai University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 weeks
Secondary	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.	6 weeks