Trial · Interventional

TerminatedPhase 4Results postedRegistry data

A Pilot Study of Pre- and Post-operative Use of Somatuline Depot.

NCTNCT01861717Other idKELD-ESS-0413

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: Didn't enroll enough subjects

Results were posted for this trial.

Overview

Status: Terminated
Phase: Phase 4
Enrollment: 4 participants (actual)
Sponsor: Saint John's Cancer Institute · Other
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
United States
Start: May 2013
Primary completion: Jan 2016
Completion: Jan 2016
First posted: 24 May 2013 (estimated)
Last update posted: 30 Sept 2021
Conditions: Acromegaly

Timeline

1 trial · 1 stopped early · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20132014201520162017

Ph 4
A Pilot Study of Pre- and Post-operative Use of Somatuline Depot.
NCT01861717
May 2013 to Jan 2016
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

lanreotideDrug

Arms1

Experimental
Somatuline Depot Subcutaneous (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.

Primary outcomes1

Outcomes the sponsor listed as primary.

Early Remission of Acromegaly
Time frame · 3 months post-op
Registry description
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.

Secondary outcomes(4)

Change in Cardiac Function
Time frame · 3 month post-op
Registry description
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
Registry description
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
Registry description
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
Registry description
Change in Quality of Life after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcome· 3 months post-op

Early Remission of Acromegaly

Group	Value
Somatuline Depot Subcutaneous (SC)	not posted

Secondary and other outcome results(5)

Secondary outcome· 3 month post-op

Change in Cardiac Function

Group	Value
Somatuline Depot SC	not posted

Secondary outcome· 3 months

Change in Hypertension

Group	Value
Somatuline Depot SC	not posted

Secondary outcome· 12 weeks and 3 months

Change in Respiratory Function

Group	Value
Somatuline Depot SC	not posted

Secondary outcome· 3 months

Change in Quality of Life

Group	Value
Somatuline Depot SC	not posted

Other pre specified outcome· 12 months post-op

Remission Status 1 Year After Surgery

Group	Value
Somatuline Depot SC	not posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Somatuline Depot SCSomatuline 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. lanreotide: Somatuline Depot 90 mg deep subcutaneous injection every 4 weeks X 3 doses	0 / 2	0 / 2	2 / 2

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 75 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * age 18 - 75 * elevated serum Insulin-like growth factor-1 (IGF-1) level above age- and sex-based normal values and failure of growth hormone(GH) suppression to \< 1.0 ng/ml after a 75 gm oral glucose tolerance test (OGTT) American Association of Clinical Endocrinolgists (AACE) Acromegaly Clinical Guidelines 2004 * visible pituitary adenoma (microadenoma or macroadenoma) on high quality pituitary MRI without and with gadolinium * prior treatments for acromegaly with surgery, somatostatin analogs or pegvisomant are acceptable if these therapies have been discontinued for at least 3 months prior to study entry Exclusion Criteria: * Age \< 18 or \> 75 years * acromegalic patients currently on a lanreotide or octreotide preparation or on pegvisomant * patients who have received prior radiotherapy or radiosurgery * patients with adenoma-related visual acuity or visual field deficit from optic nerve and/or chiasm compression or severe optic nerve/chiasm compression in the setting of normal visual fields and acuity * patients with pituitary apoplexy defined as recent tumor hemorrhage and/or infarction on MRI with associated symptoms of new onset visual loss, diplopia and/or adrenal insufficiency

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