NCT05264649

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Show Chwan Memorial Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arthralgia

Interventions

Type	Name	Description
DEVICE	acupuncture	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.
DRUG	Guizhi-Shaoyao-Zhimu decoction	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.

Timeline

• Start date: 2022-05-05
• Primary completion: 2022-07-20
• Completion: 2023-03-03
• First posted: 2022-03-03
• Last updated: 2022-11-08

Locations

1 site across 1 country: Taiwan