MacroprolactinomaNCT01143584
Efficacy of Rapid Escalation of Cabergoline in Comparison to Conventional Dosing in Prolactin Secreting Macroadenomas.
A study testing Cabergoline in people with Macroprolactinoma, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
To study the effects of rapid escalation of Cabergoline in comparison to conventional dosing in macroprolactinomas. Rapid escalation of cabergoline may help in earlier normalization of prolactin and shrinkage of tumor mass, and thus decrease the cumulative dose of cabergoline altogether. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Macroprolactinoma
- What is being tested?
- Cabergoline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIndia
- Study dates
- May 2010to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Males or females presenting with
- Prolactin secreting macroadenomas (≥10 mm maximum diameter)
- With/without visual complaints
- With /without parasellar or suprasellar extension
- Treatment Naïve
Who cannot join
- On treatment with dopamine agonists.
- Taking other drugs influencing prolactin Levels.
- Systemic disease like Chronic Kidney Disease, Chronic Lung Disease
- Other secondary causes of hyperprolactinemia.
- Prolactin secreting microadenomas
- Pregnancy during follow up
Show all 9Show fewer
- Prolactinoma as part of MEN-1 Syndrome
- History suggestive of recent apoplexy (3 months)
- Contraindication to cabergoline therapy like pre existing psychosis.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Postgraduate Institute of Medical Education and Research
Chandigarh, Chandigarh, 1700112
Anil Bhansali, MD DM, 2756583, anilbhansali_endocrine@rediffmail.com
Ashu Rastogi, MD, 09781001046, drpaed@rediffmail.com
About this study
To study the effects of rapid escalation of Cabergoline in comparison to conventional dosing in macroprolactinomas. Rapid escalation of cabergoline may help in earlier normalization of prolactin and shrinkage of tumor mass, and thus decrease the cumulative dose of cabergoline altogether.
Read the detailed description
The efficacy of cabergoline is dose related and determined by percentage of Dopamine 2 receptor occupancy and prolonged receptor affinity. Activation of membrane receptors and target cell responses is proportional to the degree of receptor occupancy. Greater the drug concentration, greater is the binding and receptor occupancy and greater is the efficacy of the drug. Receptor occupancy can be increased either by using high dose of cabergoline or by rapid escalation of cabergoline. The patients, who respond to increasing dosages of cabergoline, probably do so by increased receptor occupancy with higher doses.
Rapid escalation of doses of cabergoline is another approach to increase the drug concentration and increase the occupancy of the receptor. Earlier decrease in serum prolactin levels with rapid escalation may help in reducing the cumulative dose of cabergoline and total duration of treatment. Though studies with high doses of cabergoline have been performed in prolactinomas with normalization of prolactin levels in almost 100%, but systematic studies using rapid escalation of cabergoline in prolactinomas are lacking except the one by Bhansali et al. In their study, serum prolactin became normal in 93 per cent of the patients with a mean duration of 8.2 wk. The mean decrease in serum prolactin was 99 per cent by four weeks, however a similar decrease (93 to 99%) in prolactin was achieved in other studies with a time lag of 48 to 160 wk. This supports the notion that rapid hike in doses of cabergoline decreases serum prolactin levels faster and it becomes normal in the majority of patients earlier6. However it was an uncontrolled study with limited number of subjects.
Therefore present study was planned to study the efficacy of rapid escalation of Cabergoline versus conventional dosing in patients with macroprolactinomas. Rapid escalation of cabergoline dose may help in earlier normalization of prolactin and shrinkage of tumor mass, and thus decrease the cumulative dose of cabergoline altogether.
- Conditions
- Macroprolactinoma
- Being tested
- Cabergoline
- Keywords
- Prolactin, Cabergoline, Macroadenomas, escalation
- Medical subject headings
- Prolactinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CabergolineDrug
In the Conventional escalation group Cabergoline 0.5 mg once a week for 4 weeks and further will be incrementally dose adjusted on the basis of individual PRL values until amelioration of hyper prolactinemia @ 0.5 mg/wk every 4 weeks, till 24 weeks or until primary endpoint.
Cabergoline will be maintained at the dose at which PRL will be first normalized till primary end point.
cabergolineDrug
Also called cabergoline dopamine agonist
In the Rapid escalation group schedule of cabergoline dosing will be as follows:
Begin with 0.5 mg twice a week
- mg twice a week - second week 1.5 mg twice a week - third week
- mg twice a week - fourth week
4mg/wk would be continued for next 4 weeks. If prolactin does not normalize by 8 weeks, a repeat hike in dose of 1mg/wk will be done every 4 weekly until normalization of prolactin levels and also >50% decrease in tumor volume. Ceiling dose of Cabergoline will be 12mg/wk.
| Study group | Role | What they receive |
|---|---|---|
| Rapid escalation | Experimental | Weekly escalation of cabergoline dose in macroprolactinomas Start with 1 mg/week. increase by 1mg/wk every week till 4 weeks. after 4 weeks Cabergoline dose would be increased @1mg/wk every 4 weekly till normalization of prolactin and >50% decrease in tumor volume from baseline. Receives: Drug: cabergoline |
| Conventional escalation | Active comparator | Conventional escalation of cabergoline
In the Conventional escalation group schedule of cabergoline dosing will be 0.5 mg once a week for 4 weeks. Cabergoline will be incrementally dose adjusted on the basis of individual Prolactin values till amelioration of hyper prolactinemia @ 0.5 mg/wk every 4 weeks, till 24 weeks or till primary endpoint. Receives: Drug: Cabergoline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normoprolactinemia
Duration for normalization of serum prolactin and decrease in tumor volume >50 % from baseline.
Measured: 1 year
Secondary outcomes (1)
Duration for resolution of Hypogonadism
Duration for resolution of hypogonadism in males as defined by normal serum total testosterone 9.9-27.8nmol/L and aging male study score(AMS). In females duration to acheive regular menstrual cycles.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2010 (estimated)
- Study startMay 2010
- Primary completionDec 2011 (estimated)
- Study completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MacroprolactinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Investigators
- Anil Bhansali, MD DM, Study chair, Post Graduate Institute of Medical Education and Research, ChandigarhPinaki Dutta, MD DM, Principal investigator, Post Graduate Institute of Medical Education and Research, ChandigarhRama Walia, MD DM, Principal investigator, Post Graduate Institute of Medical Education and Research, ChandigarhParamjeet Singh, MD, Principal investigator, Post Graduate Institute of Medical Education and Research, ChandigarhVishali Gupta, MS, Principal investigator, Post Graduate Institute of Medical Education and Research, ChandigarhRajesh Vijaiwergiya, MD DM, Principal investigator, Post Graduate Institute of Medical Education and Research, ChandigarhAshu Rastogi, MD, Principal investigator, Post Graduate Institute of Medical Education and Research, ChandigarhNaresh Sachdeva, PhD, Principal investigator, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01143584
- Sponsor's protocol ID
- prlcab2020
- Status last verified
- May 2010
- First submitted
- 1 Jun 2010
- Last updated
- 14 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rastogi A, Bhansali A, Dutta P, Singh P, Vijaivergiya R, Gupta V, Sachdeva N, Bhadada SK, Walia R. A comparison between intensive and conventional cabergoline treatment of newly diagnosed patients with macroprolactinoma. Clin Endocrinol (Oxf). 2013 Sep;79(3):409-15. doi: 10.1111/cen.12149. Epub 2013 Jul 2.
PubMed 23347435
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Rapid Escalation of Cabergoline in Comparison to Conventional Dosing in Prolactin Secreting Macroadenomas.
- ClinicalTrials.gov ID
- NCT01143584
- Acronym / sponsor ID
- prlcab2020
- Conditions
- Macroprolactinoma
- Keywords
- Prolactin, Cabergoline, Macroadenomas, escalation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 14 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study the effects of rapid escalation of Cabergoline in comparison to conventional dosing in macroprolactinomas. Rapid escalation of cabergoline may help in earlier normalization of prolactin and shrinkage of tumor mass, and thus decrease the cumulative dose of cabergoline altogether.
Detailed description
The efficacy of cabergoline is dose related and determined by percentage of Dopamine 2 receptor occupancy and prolonged receptor affinity. Activation of membrane receptors and target cell responses is proportional to the degree of receptor occupancy. Greater the drug concentration, greater is the binding and receptor occupancy and greater is the efficacy of the drug. Receptor occupancy can be increased either by using high dose of cabergoline or by rapid escalation of cabergoline. The patients, who respond to increasing dosages of cabergoline, probably do so by increased receptor occupancy with higher doses.
Rapid escalation of doses of cabergoline is another approach to increase the drug concentration and increase the occupancy of the receptor. Earlier decrease in serum prolactin levels with rapid escalation may help in reducing the cumulative dose of cabergoline and total duration of treatment. Though studies with high doses of cabergoline have been performed in prolactinomas with normalization of prolactin levels in almost 100%, but systematic studies using rapid escalation of cabergoline in prolactinomas are lacking except the one by Bhansali et al. In their study, serum prolactin became normal in 93 per cent of the patients with a mean duration of 8.2 wk. The mean decrease in serum prolactin was 99 per cent by four weeks, however a similar decrease (93 to 99%) in prolactin was achieved in other studies with a time lag of 48 to 160 wk. This supports the notion that rapid hike in doses of cabergoline decreases serum prolactin levels faster and it becomes normal in the majority of patients earlier6. However it was an uncontrolled study with limited number of subjects.
Therefore present study was planned to study the efficacy of rapid escalation of Cabergoline versus conventional dosing in patients with macroprolactinomas. Rapid escalation of cabergoline dose may help in earlier normalization of prolactin and shrinkage of tumor mass, and thus decrease the cumulative dose of cabergoline altogether.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rapid escalation | Experimental | Drug: cabergolineWeekly escalation of cabergoline dose in macroprolactinomas Start with 1 mg/week. increase by 1mg/wk every week till 4 weeks. after 4 weeks Cabergoline dose would be increased @1mg/wk every 4 weekly till normalization of prolactin and >50% decrease in tumor volume from baseline. |
| Conventional escalation | Active comparator | Drug: CabergolineConventional escalation of cabergoline In the Conventional escalation group schedule of cabergoline dosing will be 0.5 mg once a week for 4 weeks. Cabergoline will be incrementally dose adjusted on the basis of individual Prolactin values till amelioration of hyper prolactinemia @ 0.5 mg/wk every 4 weeks, till 24 weeks or till primary endpoint. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Males or females presenting with
- Prolactin secreting macroadenomas (≥10 mm maximum diameter)
- With/without visual complaints
- With /without parasellar or suprasellar extension
- Treatment Naïve
Key exclusion criteria (9 listed)
- On treatment with dopamine agonists.
- Taking other drugs influencing prolactin Levels.
- Systemic disease like Chronic Kidney Disease, Chronic Lung Disease
- Other secondary causes of hyperprolactinemia.
- Prolactin secreting microadenomas
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CabergolineIn the Conventional escalation group Cabergoline 0.5 mg once a week for 4 weeks and further will be incrementally dose adjusted on the basis of individual PRL values until amelioration of hyper prolactinemia @ 0.5 mg/wk every 4 weeks, till 24 weeks or until primary endpoint. Cabergoline will be maintained at the dose at which PRL will be first normalized till primary end point. | Drug | Conventional escalation |
| cabergolineAlso: cabergoline dopamine agonistIn the Rapid escalation group schedule of cabergoline dosing will be as follows: Begin with 0.5 mg twice a week 1. mg twice a week - second week 1.5 mg twice a week - third week 2. mg twice a week - fourth week 4mg/wk would be continued for next 4 weeks. If prolactin does not normalize by 8 weeks, a repeat hike in dose of 1mg/wk will be done every 4 weekly until normalization of prolactin levels and also >50% decrease in tumor volume. Ceiling dose of Cabergoline will be 12mg/wk. | Drug | Rapid escalation |
Primary outcome
Normoprolactinemia
Time frame: 1 year
Duration for normalization of serum prolactin and decrease in tumor volume >50 % from baseline.
1 secondary outcome
Duration for resolution of Hypogonadism
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2010.
- Derived from this study: PubMed 23347435Rastogi A, Bhansali A, Dutta P, Singh P, Vijaivergiya R, Gupta V, Sachdeva N, Bhadada SK, Walia R. A comparison between intensive and conventional cabergoline treatment of newly diagnosed patients with macroprolactinoma. Clin Endocrinol (Oxf). 2013 Sep;79(3):409-15. doi: 10.1111/cen.12149. Epub 2013 Jul 2.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anil Bhansali, MD DM study chair
Post Graduate Institute of Medical Education and Research, Chandigarh
Pinaki Dutta, MD DM principal investigator
Post Graduate Institute of Medical Education and Research, Chandigarh
Rama Walia, MD DM principal investigator
Post Graduate Institute of Medical Education and Research, Chandigarh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cabergoline in people with Macroprolactinoma, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anil Bhansali, MD DM (2756583, anilbhansali_endocrine@rediffmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Normoprolactinemia (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01143584, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2010.