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

NCT01143584 | Unknown DMC

• 1 other identifier: prlcab2020
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Macroprolactinoma

Keywords

Prolactin; Cabergoline; Macroadenomas; escalation

Outcome Measures

Primary Outcomes (1)

• Normoprolactinemia

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

  1 year

Secondary Outcomes (1)

• Duration for resolution of Hypogonadism

  1 year

Study Arms (2)

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.

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.

Drug: Cabergoline

Interventions

cabergoline DRUG

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.

Conventional escalation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females presenting with
• Prolactin secreting macroadenomas (≥10 mm maximum diameter)
• With/without visual complaints
• With /without parasellar or suprasellar extension
• Treatment Naïve

You may not qualify if:

• 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.

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Postgraduate Institute of Medical Education and Research

Chandigarh, Chandigarh, 1700112, India

RECRUITING

Related Publications (1)

• 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.

  PMID: 23347435 DERIVED

MeSH Terms

Conditions

Prolactinoma

Interventions

Cabergoline

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pituitary Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Ergolines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Study Officials

• Anil Bhansali, MD DM

  Post Graduate Institute of Medical Education and Research, Chandigarh

  STUDY CHAIR

• Pinaki Dutta, MD DM

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

• Rama Walia, MD DM

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

• Paramjeet Singh, MD

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

• Vishali Gupta, MS

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

• Rajesh Vijaiwergiya, MD DM

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

• Ashu Rastogi, MD

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

• Naresh Sachdeva, PhD

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anil Bhansali, MD DM

CONTACT

2756583; anilbhansali_endocrine@rediffmail.com

Ashu Rastogi, MD

CONTACT

09781001046; drpaed@rediffmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 1, 2010
• First Posted: June 14, 2010
• Study Start: May 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: March 1, 2012
• Last Updated: June 14, 2010

Record last verified: 2010-05

Locations

IN (1)