A Pilot Study of Pre- and Post-operative Use of Somatuline Depot.
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|ClinicalTrials.gov Identifier: NCT01861717|
Recruitment Status : Terminated (Didn't enroll enough subjects)
First Posted : May 24, 2013
Last Update Posted : August 18, 2017
If someone is diagnosed with a pituitary tumor that causes acromegaly (too much growth hormone) the treatment is to have it surgically removed. This study has two phases.
The first phase provides medical treatment with a drug that will be provided for 3 months before surgery to see if complications of surgery are reduced and to see whether or not remission improves following surgery if you have this medical treatment. The drug administered is approved by the FDA for long-term treatment of acromegaly. It is not routinely administered before surgery, and is therefore experimental as used in this way. All other procedures performed during this research are standard of care with the exception of the 3 questionnaires to be completed at each visit.
The second phase of this study is from 3 months until 12 months after surgery and is only for people who do not go into remission after the operation. This phase assesses the possible remission of acromegaly after resuming the drug treatment for an additional 3 to 9 months. The drug will be prescribed by your physician as part of your regular medical care and will not be included as part of the study. All other procedures performed during this research are standard of care with the exception of the 3 questionnaires to be completed at each visit.
The study lasts approximately 16 months - 3 month before surgery and 12 months after surgery.
|Condition or disease||Intervention/treatment||Phase|
|Acromegaly||Drug: lanreotide||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Pre- and Post-operative Somatuline Depot Therapy in Acromegalic Patients Treated by Endonasal Endoscopic Surgery: Impact on Early Remission Rates and Perioperative Morbidity|
|Actual Study Start Date :||May 2013|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
Experimental: Somatuline Depot SC
Somatuline Depot SC 90mg deep subcutaneous injection every 4 weeks for 3 doses before surgery. The dose will be 60 mg for patients with mild liver or kidney dysfunction.
Somatuline Depot 90 mg deep subcutaneous injecton every 4 weeks X 3 doses
Other Name: Somatuline Depot SC
- Early remission of acromegaly [ Time Frame: 3 months post-op ]Early remission status after a 12 week course of pre-operative Somatuline Depot and 3 months after endonasal endoscopic surgery. Remission status will be based on age-adjusted Insulin Glucose Factor 1 (IGF-1) levels and oral glucose tolerance test.
- Change in cardiac function [ Time Frame: 3 month post-op ]Changes in cardiac function after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal.
- Change in hypertension [ Time Frame: 3 months ]Change in hypertension after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal
- Change in respiratory function [ Time Frame: 12 weeks and 3 months ]Change in respiratory function after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal
- Change in Quality of Life [ Time Frame: 3 months ]Change in Quality of Life after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal
- Remission status 1 year after surgery [ Time Frame: 12 months post-op ]Remission status one year after surgery and time to achieve remission in patients who did not achieve remission after endonasal endoscopic surgery and who had resumption of Somatuline Depot therapy 3 months after surgery.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01861717
|United States, California|
|Brain Tumor Center and Pituitary Disorders Program, John Wayne Cancer Institute, Saint John's Health System|
|Santa Monica, California, United States, 90404|
|Principal Investigator:||Daniel F Kelly, MD||John Wayne Cancer Institute|