An interventional study of HCQ/CQ and CAB combined treatment in Resistance, Disease and Prolactinoma, sponsored by Zhebao Wu. Status unknown at 9 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-10-16.
Sponsored by Zhebao Wu · Not applicable, Interventional, and Treatment
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
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. Chloroquine (CQ) is an old drug widely used to treat malaria. Recent studies, including our own (J Clin Endocrinol Metab, 2017; Autophagy, 2017; Oncotarget, 2015), have revealed that CAB and CQ are involved in induction of autophagy and activation of autophagic cell death. Furthermore, CQ enhanced suppression of cell proliferation by CAB. We established a low-CAB-dose condition in which CAB was able to induce autophagy but failed to suppress cell growth. Addition of CQ to low-dose CAB blocked normal autophagic cycles and induced apoptosis, evidenced by the further accumulation of p62/caspase-8/LC3-II. The data suggest that combined use of CAB and CQ may increase clinical effectiveness in treatment of intolerance and/or resistant prolactinomas.
28 studies on the registry are indexed under Prolactinoma; 5 are open to participants now.
This study's planned enrollment of 30 is below the median of 55 across 14 interventional studies indexed under Prolactinoma.
Browse Prolactinoma studies →Zhebao Wu is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects are treated with hydroxychloroquine sulfate tablets 5mg/kg Bid and cabergoline tablets 2mg/week for 3 months.
Drug: HCQ/CQ and CAB combined treatment
Subjects are treated with hydroxychloroquine sulfate tablets 5mg/kg Bid and cabergoline tablets 2mg/week for 3 months.After therapy of 3 months the medication will be stopped if does not reduce prl level more than 20% or failure to decrease prolactinoma size.
Also known as: HCCT
Change from baseline on prolactin(PRL) level
Record the result of prolactin on every 3 month follow-up visit
Time frame: Up to 6 months
Change from baseline on tumor volume measured by enhanced pituitary Magnetic Resonance Imaging（MRI）
Record the tumor volume from enhanced pituitary MRI on every 3 month follow-up visits
Time frame: Up to 6 months
Change from baseline of visual acuity
Record the Visual acuity on every 3 month follow-up visit
Time frame: Up to 6 months
Change from baseline on 5 point visual field scale
Record the Visual field scale on every 3 month follow-up visit, 0 = normal, no vision loss; 1 = one quadrant vision loss; 2 = two quadrants of vision loss; 3 = three quadrants of vision loss; 4 = four quadrants of vision loss but retain a central tubular vision; 5 = blind
Time frame: Up to 6 months
Plan to share: Undecided — The individual patient Data would not be shared to the third facility, but the sponsor hasn't decided whether to share the individual patient date to the other related studies hold by himself in the future.
Start is estimated for Oct 2018; primary completion for Dec 2020, 26 months later.
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This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Zhebao Wu