Clinical trial NCT05098951: Acupuncture for Stiffness of Joint Related to Aromatase Inhibitors in Patients With Early-Stage Breast Cancer
Official title: Efficacy and Safety of Acupuncture for Relieving Stiffness of Joint Related to Aromatase Inhibitors in Patients With Early-Stage Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Stiffness of Hand, Not Elsewhere Classified
Keywords: Breast cancer
Stiffness
Aromatase inhibitor
Acupuncture
High altitude
Lead sponsor: Affiliated Hospital of Qinghai University
Sponsor class: OTHER
First posted: 2021-10-29
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: The change in stiffness score as measured by the Western Ontario and McMasters Universities Osteoarthritis (WOMAC)
timeFrame: 6 weeks
Secondary outcomes:
measure: The change in stiffness score as measured by the Modified Score for the Assessment of Chronic Rheumatoid Affections of the Hands (M-SACRAH)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Xining
country: China
facility: Affiliated Hospital of Qinghai University, Affiliated Cancer Hospital of Qinghai University
state: Qinghai
Study officials:
affiliation: the Affiliated Hospital of Qinghai University
name: Jiuda Zhao
role: PRINCIPAL_INVESTIGATOR
References: