Status:
UNKNOWN
Cabergoline Combined Hydroxychloroquine/Chloroquine to Treat Resistant Prolactinomas
Lead Sponsor:
Zhebao Wu
Collaborating Sponsors:
Xinqiao Hospital of Chongqing
First Hospital of China Medical University
Conditions:
Resistance, Disease
Prolactinoma
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The purpose of this study is to preliminarily evaluate the safety and efficacy of cabergoline combined hydroxychloroquine/chloroquine(HCQ/CQ) therapy for cabergoline-Resistant Prolactinomas
Detailed Description
The dopamine agonist cabergoline (CAB) has been used widely in the treatment of prolactinomas, but its clinical use is hampered by intolerance and/or resistant in some patients with prolactinoma. Chlo...
Eligibility Criteria
Inclusion
- Aged between 18 and 70 years old, either sex;
- Karnofsky performance status ≥ 70;
- Patients who were suffered drug-resistant,which has taken cabergoline ≥2.0mg/week no less than 3 months, referring to failure to normalize PRL levels and failure to decrease macroprolactinoma size by \>or=50%;
- The patient has signed the informed consent.
Exclusion
- Patients concomitantly taking the psychotropic drugs or other drugs causing elevated PRL ;
- Patients with parkinson disease and is taking dopaminergic agents;
- Patients with prolactinoma who received Gamma knife treatment;
- Patients who use any dopamine receptor agonists other than cabergoline;
- pregnant or lactating women, or women preparing pregnant;
- Patients with poor compliance, who cannot implement the program strictly.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to HCQ.
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency, as HCQ may cause hemolytic anemia in patients with G6PD deficiency.
Key Trial Info
Start Date :
October 25 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03400865
Start Date
October 25 2018
End Date
December 30 2020
Last Update
October 16 2018
Active Locations (9)
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1
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
2
Huashan Hospital
Shanghai, Shanghai Municipality, China, 200025
3
Ruijin Hosipital
Shanghai, Shanghai Municipality, China, 200025
4
Chinese PLA General Hospital
Beijing, China