Hormonal Outcomes in Acromegalic Patients With Treated Surgery With or Without Long Acting Somatostatin Analogues (acromegaly)

Long-term (up to 3 Years) Clinical and Hormonal Outcomes in Acromegalic Patients With Treated Surgery With or Without Long Acting Somatostatin Analogues: Open-labeled, Prospective, Parallel Group Study

Long-term (up to 3 years) clinical and hormonal outcomes in acromegalic patients with treated surgery with or without long acting somatostatin analogues.

Study Overview

• Status: Unknown
• Conditions: Acromegaly
• Intervention / Treatment: Drug: Sandostatin (Octreotide Acetate)

Detailed Description

Patients who are diagnosed with acromegaly with a GH-secreting pituitary adenoma receiving TSA at the Asan Medical Center (Seoul, Korea) from Aug 2013 to Aug 2015 will be recruited.

The eligible patient population will consist of 30 adult, male and female patient with Age 18 or older.

• Number of patients by treatment group: Surgical treatment only = 15, Surgery with medical treatment = 15
• Number of Centers: 1 (single center)

• Study Type: Interventional
• Enrollment (Anticipated): 1
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 138-736
    • Recruiting
    • Asan Medical Center
    • Contact: minseon Kim, PhD; Phone Number: 82-2-3010-3245; Email: mskim@amc.seoul.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 18 or older.
2. Patients diagnosed with acromegaly with GH-secreting pituitary adenoma on sellar MRI, meeting the biochemical criteria outlined above (refer to 1. Diagnosis of acromegaly) and with typical acromegalic features.
3. No prior use of somatostatin analogues.
4. Adequate hepatic and renal function
5. Provision of a signed written informed consent

Exclusion Criteria:

1. Severe co-morbid illness such as untreatable other malignancy and/or active infections.
2. Pregnant or lactating women
3. Hypersensitivity to Sandostatin or any component of the formulation.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 2: Surgery + Medical treatment; MRI : residual tumor 6 months post-op : IGF-1 >600 ng/ml medical treatment : Sandostatin (Octreotide Acetate)	Drug: Sandostatin (Octreotide Acetate); For the patients outlined above (refer to 2), subjects who are not able to be treated by surgery alone: Dose: Sandostatin LAR® 20mg per 4 weeks for 3 months -> If serum IFG-1 levels fails to normalize, the dose of LAR will be increased to 30 mg.; Frequency: every 4 weeks.; Route of administration: IM injection.; Other Names: Sandostatin LAR
No Intervention: Group 3 : Rescue group; If IGF-1 levels fails to normalize till post-op 18 months post-op, medical treatment will be added.)
No Intervention: Gruop1 : Surgery only group; MRI : without residual tumor 6months post-operation and IGF-1 <600ng/ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients who achieved normalization of fasting serum IGF-1 (age and sex matched)	Change from within 3days post-operative in fasting serum IGF-1at 36 months post-operative
The time taken to IGF-1 normalization in each group.	Change from within 3days post-operative in IGF-1 normalization at 36 months post-operative months post-operative

Secondary Outcome Measures

Outcome Measure	Time Frame
GH suppressive responses (a nadir GH < 0.4 ng/ml) to oral glucose	Change from Pre-operative in GH suppressive responses (a nadir GH < 0.4 ng/ml) at 36 months post-operative
Clinical symptom and sign with AcroQoL questionnaire	Change from Pre-operative in Clinical symptom and sign with AcroQoL questionnaire at 36 months post-operative
Sleep quality and disturbance with written questionnaire	Change from Pre-operative in Sleep quality and disturbance with written questionnaire at 24 months post-operative
fasting glucose , postprandial glucose	Change from pre-operative in fasting glucose , postprandial glucose at 36 months post-operative.
insulin	Change from pre-operative in insulin at 36 months post-operative.
HbA1c	change from pre-operative in HbA1c at 36 months post-operative.

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Collaborators: Novartis Korea Ltd.
• Investigators: Principal Investigator: minseon Kim, PhD, Asan Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: February 4, 2015
• First Submitted That Met QC Criteria: April 22, 2015
• First Posted (Estimate): April 28, 2015

Study Record Updates

• Last Update Posted (Estimate): April 28, 2015
• Last Update Submitted That Met QC Criteria: April 22, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Musculoskeletal Diseases; Hypothalamic Diseases; Bone Diseases; Bone Diseases, Endocrine; Hyperpituitarism; Pituitary Diseases; Acromegaly; Antineoplastic Agents; Gastrointestinal Agents; Antineoplastic Agents, Hormonal; Octreotide
• Other Study ID Numbers: CSMS995BKR08T