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

Primary Purpose

Macroprolactinoma

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Cabergoline
cabergoline
Sponsored by
Postgraduate Institute of Medical Education and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macroprolactinoma focused on measuring Prolactin, Cabergoline, Macroadenomas, escalation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Postgraduate Institute of Medical Education and ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Rapid escalation

Conventional escalation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Normoprolactinemia
Duration for normalization of serum prolactin and decrease in tumor volume >50 % from baseline.

Secondary Outcome Measures

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.

Full Information

First Posted
June 1, 2010
Last Updated
June 11, 2010
Sponsor
Postgraduate Institute of Medical Education and Research
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1. Study Identification

Unique Protocol Identification Number
NCT01143584
Brief Title
Efficacy of Rapid Escalation of Cabergoline in Comparison to Conventional Dosing in Prolactin Secreting Macroadenomas.
Official Title
Efficacy of Rapid Escalation of Cabergoline in Comparison to Conventional Dosing in Prolactin Secreting Macroadenomas.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Unknown status
Study Start Date
May 2010 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
March 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Postgraduate Institute of Medical Education and Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macroprolactinoma
Keywords
Prolactin, Cabergoline, Macroadenomas, escalation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rapid escalation
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional escalation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Cabergoline
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
cabergoline
Other Intervention Name(s)
cabergoline dopamine agonist
Intervention Description
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.
Primary Outcome Measure Information:
Title
Normoprolactinemia
Description
Duration for normalization of serum prolactin and decrease in tumor volume >50 % from baseline.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Duration for resolution of Hypogonadism
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males or females presenting with Prolactin secreting macroadenomas (≥10 mm maximum diameter) With/without visual complaints With /without parasellar or suprasellar extension Treatment Naïve Exclusion Criteria: 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 Prolactinoma as part of MEN-1 Syndrome History suggestive of recent apoplexy (3 months) Contraindication to cabergoline therapy like pre existing psychosis.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anil Bhansali, MD DM
Phone
2756583
Email
anilbhansali_endocrine@rediffmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ashu Rastogi, MD
Phone
09781001046
Email
drpaed@rediffmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anil Bhansali, MD DM
Organizational Affiliation
Postgraduate Institute of Medical Education and Research
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Pinaki Dutta, MD DM
Organizational Affiliation
Postgraduate Institute of Medical Education and Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rama Walia, MD DM
Organizational Affiliation
Postgraduate Institute of Medical Education and Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paramjeet Singh, MD
Organizational Affiliation
Postgraduate Institute of Medical Education and Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vishali Gupta, MS
Organizational Affiliation
Postgraduate Institute of Medical Education and Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rajesh Vijaiwergiya, MD DM
Organizational Affiliation
Postgraduate Institute of Medical Education and Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ashu Rastogi, MD
Organizational Affiliation
Postgraduate Institute of Medical Education and Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Naresh Sachdeva, PhD
Organizational Affiliation
Postgraduate Institute of Medical Education and Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Postgraduate Institute of Medical Education and Research
City
Chandigarh
ZIP/Postal Code
1700112
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anil Bhansali, MD DM
Phone
2756583
Email
anilbhansali_endocrine@rediffmail.com
First Name & Middle Initial & Last Name & Degree
Ashu Rastogi, MD
Phone
09781001046
Email
drpaed@rediffmail.com
First Name & Middle Initial & Last Name & Degree
Anil Bhansali, MD DM

12. IPD Sharing Statement

Citations:
PubMed Identifier
23347435
Citation
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.
Results Reference
derived

Learn more about this trial

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

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