An interventional study of Diclofenac in Breast Cancer, sponsored by China Medical University Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2022-07-20.
Sponsored by China Medical University Hospital · Not applicable, Interventional, and Other
Hormone therapy is used to treat women with hormone receptor-positive breast cancer and aromatase inhibitor (AI) is administered after menopause. AI therapy has been proven to be effective in improving the disease-free survival rate, decreasing the recurrence rates and a lower incidence of contralateral breast cancer. However, arthralgia frequently reported as an important adverse event of AI therapy and sometimes resulted in noncompliance with AI therapy. The prevalence of AI induced arthralgia rates ranged from 20 to 74%. Inadequately managed AI induced arthralgia remains a major unmet need in oncology practice in breast cancer survivors.
The goal of this project is to conduct a crossover designed pragmatic clinical trial to evaluate the effectiveness of acupuncture versus NSAID (Diclofenac) for the management of aromatase inhibitor induced arthralgia.
The third group was set to use non-steroidal analgesics plus acupuncture to evaluate the effectiveness of joint pain.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's enrollment of 54 is below the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →China Medical University Hospital is the lead sponsor of 479 studies on the registry; 115 are open to participants now.
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Exclusion Criteria:
Drug: Diclofenac
Drug: Diclofenac
Drug: Diclofenac
Patients who were diagnosed as breast cancer and met the inclusion criteria will be recruited and randomly assigned to acupuncture group or drug (NSAIDs) group. After each subgroup completing the 4 weeks intervention, all the participants were enter washout period lasting 2 weeks to eliminate the effect of the previous treatment. Crossover was held after washout period and made the patients to have the other treatment in the following 4 weeks. After receiving the case, the third group recorded the pain indicators for the first month, followed by a one-month trial- combination of acupuncture and NSAID treatment, and then followed up for another month after stopping.
Acupuncture can improve joint symptoms resulting from aromatase inhibitor and quality of life
Patients will be asked to complete a baseline questionnaire covering demographic information and reproductive history. At baseline and at 4, 6 and 10 weeks, self-administered questionnaires including the 10mm visual analogue scales. Follow-up assessments will be conducted at the 4 weeks after the end of intervention. According to statistically estimation, we compare the changes between three subgroups and hypothesize 20% difference as significant effect after intervention. We use ANOVA to calculate the sample size with an alpha of 0.05 as significance level, approximately 80% power and 20% drop-out rate. The trial will enroll 145 participants.
Time frame: one year
Ran from Mar 2018 to primary completion in Dec 2021, 45 months.
Of 2,272 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 69. This study's 45 months is above that.
Counting every sponsor, half of 2,345 studies reached it within 34 months; a quarter within 16 and three quarters within 69.
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This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Diclofenac
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