Efficacy of Rapid Escalation of Cabergoline in Comparison to Conventional Dosing in Prolactin Secreting Macroadenomas.

June 11, 2010 updated by: Postgraduate Institute of Medical Education and Research
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Chandigarh, India, 1700112
        • Recruiting
        • Postgraduate Institute of Medical Education and Research
        • Contact:
        • Contact:
        • Principal Investigator:
          • Anil Bhansali, MD DM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Males or females presenting with

  1. Prolactin secreting macroadenomas (≥10 mm maximum diameter)
  2. With/without visual complaints
  3. With /without parasellar or suprasellar extension
  4. Treatment Naïve

Exclusion Criteria:

  1. On treatment with dopamine agonists.
  2. Taking other drugs influencing prolactin Levels.
  3. Systemic disease like Chronic Kidney Disease, Chronic Lung Disease
  4. Other secondary causes of hyperprolactinemia.
  5. Prolactin secreting microadenomas
  6. Pregnancy during follow up
  7. Prolactinoma as part of MEN-1 Syndrome
  8. History suggestive of recent apoplexy (3 months)
  9. Contraindication to cabergoline therapy like pre existing psychosis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rapid escalation
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.
Drug: cabergoline

In 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.

Other Names:
  • cabergoline dopamine agonist
Active Comparator: Conventional escalation

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.
Drug: Cabergoline

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Normoprolactinemia
Time Frame: 1 year
Duration for normalization of serum prolactin and decrease in tumor volume >50 % from baseline.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration for resolution of Hypogonadism
Time Frame: 1 year
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Postgraduate Institute of Medical Education and Research

Investigators

  • Study Chair: Anil Bhansali, MD DM, Postgraduate Institute of Medical Education and Research
  • Principal Investigator: Pinaki Dutta, MD DM, Postgraduate Institute of Medical Education and Research
  • Principal Investigator: Rama Walia, MD DM, Postgraduate Institute of Medical Education and Research
  • Principal Investigator: Paramjeet Singh, MD, Postgraduate Institute of Medical Education and Research
  • Principal Investigator: Vishali Gupta, MS, Postgraduate Institute of Medical Education and Research
  • Principal Investigator: Rajesh Vijaiwergiya, MD DM, Postgraduate Institute of Medical Education and Research
  • Principal Investigator: Ashu Rastogi, MD, Postgraduate Institute of Medical Education and Research
  • Principal Investigator: Naresh Sachdeva, PhD, Postgraduate Institute of Medical Education and Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

March 1, 2012

Study Registration Dates

First Submitted

June 1, 2010

First Submitted That Met QC Criteria

June 11, 2010

First Posted (Estimate)

June 14, 2010

Study Record Updates

Last Update Posted (Estimate)

June 14, 2010

Last Update Submitted That Met QC Criteria

June 11, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • prlcab2020

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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