Clinical trial · Interventional
Cabergoline Combined Hydroxychloroquine/Chloroquine to Treat Resistant Prolactinomas
The Effect of Combined Treatment of Cabergoline With Hydroxychloroquine/Chloroquine for Resistant Prolactinomas
NCT03400865CI-TRIAL-00035295unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prolactinoma | Lactotroph Pituitary Neuroendocrine Tumor | ALIAS | 0.90 |
| Resistance, Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HCQ/CQ and CAB combined treatment | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HCQ/CQ and CAB combined treatment
- description
- Subjects are treated with hydroxychloroquine sulfate tablets 5mg/kg Bid and cabergoline tablets 2mg/week for 3 months.
- interventionNames
- Drug: HCQ/CQ and CAB combined treatment
Primary outcomes (1)
- measure
- Change from baseline on prolactin(PRL) level
- timeFrame
- Up to 6 months
- description
- Record the result of prolactin on every 3 month follow-up visit
Secondary outcomes (3)
- measure
- Change from baseline on tumor volume measured by enhanced pituitary Magnetic Resonance Imaging（MRI）
- timeFrame
- Up to 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Aged between 18 and 70 years old, either sex; 2. Karnofsky performance status ≥ 70; 3. 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%; 4. The patient has signed the informed consent. Exclusion Criteria: 1. Patients concomitantly taking the psychotropic drugs or other drugs causing elevated PRL ; 2. Patients with parkinson disease and is taking dopaminergic agents; 3. Patients with prolactinoma who received Gamma knife treatment; 4. Patients who use any dopamine receptor agonists other than cabergoline; 5. pregnant or lactating women, or women preparing pregnant; 6. Patients with poor compliance, who cannot implement the program strictly. 7. History of allergic reactions attributed to compounds of similar chemical or biologic composition to HCQ. 8. Glucose-6-phosphate dehydrogenase (G6PD) deficiency, as HCQ may cause hemolytic anemia in patients with G6PD deficiency.
References
Publications (3)
- BACKGROUNDLeng ZG, Lin SJ, Wu ZR, Guo YH, Cai L, Shang HB, Tang H, Xue YJ, Lou MQ, Zhao W, Le WD, Zhao WG, Zhang X, Wu ZB. Activation of DRD5 (dopamine receptor D5) inhibits tumor growth by autophagic cell death. Autophagy. 2017 Aug 3;13(8):1404-1419. doi: 10.1080/15548627.2017.1328347. Epub 2017 Jun 14. PMID 28613975
- BACKGROUNDLin SJ, Leng ZG, Guo YH, Cai L, Cai Y, Li N, Shang HB, Le WD, Zhao WG, Wu ZB. Suppression of mTOR pathway and induction of autophagy-dependent cell death by cabergoline. Oncotarget. 2015 Nov 17;6(36):39329-41. doi: 10.18632/oncotarget.5744. PMID 26513171
- RESULTLin SJ, Wu ZR, Cao L, Zhang Y, Leng ZG, Guo YH, Shang HB, Zhao WG, Zhang X, Wu ZB. Pituitary Tumor Suppression by Combination of Cabergoline and Chloroquine. J Clin Endocrinol Metab. 2017 Oct 1;102(10):3692-3703. doi: 10.1210/jc.2017-00627. PMID 28973192