Clinical trial NCT05264649: Effect of Acupuncture vs Chinese Medicine vs Combined Therapy on Aromatase Inhibitor-related Arthralgia Among Women With Early-Stage Breast Cancer
Official title: Effect of Acupuncture vs Chinese Medicine vs Combined Therapy on Aromatase Inhibitor-related Arthralgia Among Women With Early-Stage Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arthralgia
Keywords: aromatase inhibitors-associated arthralgia
aromatase inhibitors
breast cancer
musculoskeletal disorders
hormonal anti-estrogen therapy
endocrine therapy
Lead sponsor: Show Chwan Memorial Hospital
Sponsor class: OTHER
First posted: 2022-03-03
Enrollment: 72
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Reduce estrogen exposure can lower the risk of breast cancer recurrence. Aromatase inhibitors have been used to treat hormone receptor positive breast cancer women in menopause for years. It can increase the survival rate and decrease the chance of recurrence. However, many patients suffered from the side effects of medication, including joint pain, is the main reason for decreasing medication adherence and influencing patients' quality of life. Based on previous phase III clinical trial study, acupuncture may relieve aromatase inhibitor associated joint pain, and experts believe that acupuncture could also be considered as an effective adjuvant treatment. Chinese herbs or acupuncture provides promising clinical effects and plays an important role in alleviating the side effects of cancer treatment. Guizhi-Shaoyao-Zhimu decoction has frequently being prescribed to treat joint pain in traditional Chinese medicine practice. The design of this clinical trial will evaluate the effects of the acupuncture, Chinese medicine, and the combination of both on joint pain related to aromatase inhibitors among women with early-stage breast cancer. The goal of this study was to evaluate the efficacy and safety with regards to utilizing acupuncture and Chinese herbs in treating joint pain related to the usage of aromatase inhibitors.

Eligibility criteria: Inclusion Criteria:

1. 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).
2. Post- or pre-menopausal with the use of a gonadotropin-releasing hormone agonist.
3. Taking AIs for more than 30 days before registration and planned to continue treatment for over 1 year.
4. Have already been recovered from the surgery or chemotherapy.
5. Have a ECOG performance status score of 0 to 1.
6. 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.
7. Have a Eastern Cooperative Oncology Group (ECOG) grading scale for chemotherapy-induced peripheral neuropathy score of 1 to 2.
8. The patient could cooperate the intervention and sign the informed consent.

Exclusion Criteria:

1. 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.
2. Had a history of fractures or underwent surgery on the knee or hand joints in the past six months.
3. Had severe bleeding disorders. The platelet counts are below 50,000 per μl.
4. Cognitive disorders (included dementia).
5. Lymphedema after breast cancer surgery.

Primary outcomes:
measure: Brief Pain Inventory-Worst Pain Item (BFI-WP)
timeFrame: Change from baseline at 6 weeks
Secondary outcomes:
measure: Brief Pain Inventory - Short Form (BPI-SF)
timeFrame: Change from baseline at 6 weeks
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: Change from baseline at 6 weeks
measure: Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH)
timeFrame: Change from baseline at 6 weeks
measure: Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES)
timeFrame: Change from baseline at 6 weeks
Other outcomes:
Locations:
city: Changhua
country: Taiwan
facility: ShowChwanMH
Study officials:
affiliation: Show Chwan Memorial Hospital
name: I-Ting Lee, Bachelor
role: PRINCIPAL_INVESTIGATOR
References: