Effect of Acupuncture vs Chinese Medicine vs Combined Therapy on Aromatase Inhibitor-related Arthralgia Among Women With Early-Stage Breast Cancer

Not Applicable

Recruiting

• Conditions: Arthralgia
• Interventions: Device: acupuncture; Drug: Guizhi-Shaoyao-Zhimu decoction

• Registration Number: NCT05264649
• Lead Sponsor: Show Chwan Memorial Hospital

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.

Study Timeline

• Study First Submitted: 2022-02-20
• Study First Submitted QC: 2022-03-02
• Study First Posted: 2022-03-03
• Study Start: 2022-05-05
• Primary Completion: 2022-07-20
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-06
• Last Update Posted: 2022-11-08
• Study Completion: 2023-03-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
acupuncture group	acupuncture	Stainless 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	Guizhi-Shaoyao-Zhimu decoction	The 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	acupuncture	The combined group would have both acupuncture and Chinese medicine interventions.
combined group	Guizhi-Shaoyao-Zhimu decoction	The combined group would have both acupuncture and Chinese medicine interventions.

Primary Outcome Measures

Name	Time	Method
Brief Pain Inventory-Worst Pain Item (BFI-WP)	Change from baseline at 6 weeks	a 0- to 10-point scale (0 \[no pain\] to 10 \[pain as bad as you can imagine)

Secondary Outcome Measures

Name	Time	Method
Brief Pain Inventory - Short Form (BPI-SF)	Change from baseline at 6 weeks	The Brief Pain Inventory-Short Form (BPI-SF) was used to evaluate the worst pain, pain severity, and pain- related interference scores. (0 \[no pain\] to 10 \[pain as bad as you can imagine)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	Change from baseline at 6 weeks	The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was used in the evaluation of pain (score range, 0-20), stiffness (score range, 0-8), physical function of lower limb (score range, 0-68).
Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH)	Change from baseline at 6 weeks	Affections of the Hands (M-SACRAH) was used in the evaluation of pain, stiffness, physical function of upper limb.
Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES)	Change from baseline at 6 weeks	The Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) measured physical and functional well- being and endocrine symptoms (score range, 0-128)

Trial Locations

Locations (1)

ShowChwanMH; 🇨🇳 Changhua, Taiwan