Effect of Acupuncture vs Chinese Medicine vs Combined Therapy on Aromatase Inhibitor-related Arthralgia Among Women With Early-Stage Breast Cancer
1 other identifier
interventional
72
1 country
1
Brief Summary
Aromatase inhibitors have been used to treat hormone receptor positive breast cancer women in menopause, but side effects, such as joint pain, would affect their qualities of life. Chinese herbs or acupuncture provides promising clinical effects and plays an important role on alleviating the side effects of cancer treatment. This clinical trial will evaluate the effect of the acupuncture, Chinese medicine, and the combination of both on joint pain related to aromatase inhibitors among women with early-stage breast cancers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2022
CompletedFirst Posted
Study publicly available on registry
March 3, 2022
CompletedStudy Start
First participant enrolled
May 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 3, 2023
CompletedNovember 8, 2022
November 1, 2022
3 months
February 20, 2022
November 6, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Brief Pain Inventory-Worst Pain Item (BFI-WP)
a 0- to 10-point scale (0 \[no pain\] to 10 \[pain as bad as you can imagine)
Change from baseline at 6 weeks
Secondary Outcomes (4)
Brief Pain Inventory - Short Form (BPI-SF)
Change from baseline at 6 weeks
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Change from baseline at 6 weeks
Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH)
Change from baseline at 6 weeks
Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES)
Change from baseline at 6 weeks
Study Arms (3)
acupuncture group
EXPERIMENTALStainless steel, disposable, sterile needles choosing based on the needs of different body parts (0.22 gauge x 25mm, 0.22 gauge x 40mm, or 0.25 gauge x 100mm) were inserted to acupoints at traditional depths and angles.
Chinese medicine group
EXPERIMENTALThe Chinese medicine group used Guizhi-Shaoyao-Zhimu decoction (GZSD) as their medical intervention. The GZSD samples were made and packed by Sun Ten Pharmaceutical Co. Ltd., a firm that meets the requirements of the good manufacturing practice (GMP) certification in Taiwan. Every 4g of concentrated GZSD was sealed in an isolated paper drug bag.
combined group
EXPERIMENTALThe combined group would have both acupuncture and Chinese medicine interventions.
Interventions
The acupuncture group were consisted of twelve 30 minutes sessions 2 times per week sessions for 6 weeks. The acupoints were included full body protocol (LI4, LR3, and PC7) and joint-specific protocol tailored as many as three of the patient's most painful joint areas. After 20 minutes "De Qi" reported by patients, needles were restimulated manually and removed after an additional 10 minutes.
The patients consumed GZSD (4g paper bagged medicine) three times per day (total daily dose was 12 g/day) continuously during the 6-week intervention period.
Eligibility Criteria
You may qualify if:
- Women with diagnosis of early breast cancer (stages I-III), expressing hormone receptor-positive (ER+, PR+, or both) and took third generation aromatase inhibitors (AIs).
- Post- or pre-menopausal with the use of a gonadotropin-releasing hormone agonist.
- Taking AIs for more than 30 days before registration and planned to continue treatment for over 1 year.
- Have already been recovered from the surgery or chemotherapy.
- Have a ECOG performance status score of 0 to 1.
- Joint pain which has developed or worsened since starting AIs therapy. The worst pain item score of Brief Pain Inventory-Short Form (BPI-SF) is at least 3 and above.
- Have a Eastern Cooperative Oncology Group (ECOG) grading scale for chemotherapy-induced peripheral neuropathy score of 1 to 2.
- The patient could cooperate the intervention and sign the informed consent.
You may not qualify if:
- Had received acupuncture treatment for joint pain would be excluded, but patients with acupuncture treatment for less than 2 times due to other reasons could be included.
- Had a history of fractures or underwent surgery on the knee or hand joints in the past six months.
- Had severe bleeding disorders. The platelet counts are below 50,000 per μl.
- Cognitive disorders (included dementia).
- Lymphedema after breast cancer surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ShowChwanMH
Changhua, 500, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
I-Ting Lee, Bachelor
Show Chwan Memorial Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- doctor
Study Record Dates
First Submitted
February 20, 2022
First Posted
March 3, 2022
Study Start
May 5, 2022
Primary Completion
July 20, 2022
Study Completion
March 3, 2023
Last Updated
November 8, 2022
Record last verified: 2022-11