Short and Long Term Efficacy of Combined Cabergoline and Octreotide Treatment in Acromegalic Patients

NCT01014793 | Completed DMC

• 1 other identifier: Mattapr1
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

In acromegaly, nearly 40% of patients fail to control GH/IGF-I levels with somatostatin analogues (SA). Dopaminergic agonists (DA) are even less effective, but combination therapy with SA and DA normalizes IGF-I levels in 33-56% of patients in short-term studies. This study was designed to evaluate short and long term efficacy of cabergoline in controlling IGF-I levels in acromegalic patients receiving octreotide.

Conditions

Acromegaly

Keywords

Acromegaly resistant; combined-treatment; dopamine agonist

Outcome Measures

Primary Outcomes (1)

• Control of IGF-I levels

  six months

Secondary Outcomes (1)

• control IGI-I levels

  six months

Study Arms (1)

Responders to cabergoline

patients with active disease under octreotide treatment received addition of increasing doses of cabergoline (1.0, 2.0 and 3.5mg/week)

Drug: cabergoline

Interventions

cabergoline DRUG

cabergoline doses were increased at 6-week intervals, starting at 1.0mg/week followed by 2.0 and 3.5mg/week. Hormonal evaluations (IGF-I, GH and PRL) started before the first dose and were repeated at 6-week intervals after each cabergoline dose and after cabergoline withdrawal

Also known as: cabergoline-Dostinex

Responders to cabergoline

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Nineteen acromegalic patients (Neuroendocrine Unit-UNIFESP)with active disease, resistant to octreotide were enrolled

You may qualify if:

• Active disease, under octreotide treatment at least 9 months

You may not qualify if:

• Cabergoline allergy

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Federal University of Sao Paulo

São Paulo, São Paulo, 04039030, Brazil

Location

Related Publications (9)

• Rocheville M, Lange DC, Kumar U, Sasi R, Patel RC, Patel YC. Subtypes of the somatostatin receptor assemble as functional homo- and heterodimers. J Biol Chem. 2000 Mar 17;275(11):7862-9. doi: 10.1074/jbc.275.11.7862.

  PMID: 10713101 BACKGROUND

• Holdaway IM, Rajasoorya RC, Gamble GD. Factors influencing mortality in acromegaly. J Clin Endocrinol Metab. 2004 Feb;89(2):667-74. doi: 10.1210/jc.2003-031199.

  PMID: 14764779 BACKGROUND

• Melmed S, Colao A, Barkan A, Molitch M, Grossman AB, Kleinberg D, Clemmons D, Chanson P, Laws E, Schlechte J, Vance ML, Ho K, Giustina A; Acromegaly Consensus Group. Guidelines for acromegaly management: an update. J Clin Endocrinol Metab. 2009 May;94(5):1509-17. doi: 10.1210/jc.2008-2421. Epub 2009 Feb 10.

  PMID: 19208732 BACKGROUND

• Cozzi R, Attanasio R, Lodrini S, Lasio G. Cabergoline addition to depot somatostatin analogues in resistant acromegalic patients: efficacy and lack of predictive value of prolactin status. Clin Endocrinol (Oxf). 2004 Aug;61(2):209-15. doi: 10.1111/j.1365-2265.2004.02082.x.

  PMID: 15272916 RESULT

• Selvarajah D, Webster J, Ross R, Newell-Price J. Effectiveness of adding dopamine agonist therapy to long-acting somatostatin analogues in the management of acromegaly. Eur J Endocrinol. 2005 Apr;152(4):569-74. doi: 10.1530/eje.1.01888.

  PMID: 15817912 RESULT

• Abs R, Verhelst J, Maiter D, Van Acker K, Nobels F, Coolens JL, Mahler C, Beckers A. Cabergoline in the treatment of acromegaly: a study in 64 patients. J Clin Endocrinol Metab. 1998 Feb;83(2):374-8. doi: 10.1210/jcem.83.2.4556.

  PMID: 9467544 RESULT

• Rocheville M, Lange DC, Kumar U, Patel SC, Patel RC, Patel YC. Receptors for dopamine and somatostatin: formation of hetero-oligomers with enhanced functional activity. Science. 2000 Apr 7;288(5463):154-7. doi: 10.1126/science.288.5463.154.

  PMID: 10753124 RESULT

• Jallad RS, Bronstein MD. Optimizing medical therapy of acromegaly: beneficial effects of cabergoline in patients uncontrolled with long-acting release octreotide. Neuroendocrinology. 2009;90(1):82-92. doi: 10.1159/000218323. Epub 2009 May 8.

  PMID: 19439914 RESULT

• Gatta B, Hau DH, Catargi B, Roger P, Tabarin A. Re-evaluation of the efficacy of the association of cabergoline to somatostatin analogues in acromegalic patients. Clin Endocrinol (Oxf). 2005 Oct;63(4):477-8. doi: 10.1111/j.1365-2265.2005.02329.x. No abstract available.

  PMID: 16181243 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum for IGI-I, GH and prolactin measures

MeSH Terms

Conditions

Acromegaly

Interventions

Cabergoline

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; 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

• Julio Abucham, PhD

  Federal University of São Paulo

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 16, 2009
• First Posted: November 17, 2009
• Study Start: May 1, 2005
• Primary Completion: May 1, 2007
• Study Completion: December 1, 2008
• Last Updated: November 17, 2009

Record last verified: 2009-11

Locations

BR (1)