NCT01861717 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE4
Status at capture: TERMINATED
Registry last update: 2021-09-30

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Early Remission of Acromegaly

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outcome · POSTED

Change in Cardiac Function

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outcome · POSTED

Change in Hypertension

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outcome · POSTED

Change in Respiratory Function

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outcome · POSTED

Change in Quality of Life

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outcome · POSTED

Remission Status 1 Year After Surgery

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: 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
healthy Volunteers: false
maximum Age: 75 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
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.
intervention Names
Drug: lanreotide
label
Somatuline Depot Subcutaneous (SC)
type
EXPERIMENTAL

interventions

arm Group Labels
Somatuline Depot Subcutaneous (SC)
description
Somatuline Depot 90 mg deep subcutaneous injection every 4 weeks X 3 doses
name
lanreotide
other Names
Somatuline Depot SC
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 4
type: ACTUAL

Registered outcome plans (not posted results)

other Outcomes

description
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.
measure
Remission Status 1 Year After Surgery
time Frame
12 months post-op

primary Outcomes

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.
measure
Early Remission of Acromegaly
time Frame
3 months post-op

secondary Outcomes

description
Changes in cardiac function after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal.
measure
Change in Cardiac Function
time Frame
3 month post-op
description
Change in hypertension after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal
measure
Change in Hypertension
time Frame
3 months
description
Change in respiratory function after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal
measure
Change in Respiratory Function
time Frame
12 weeks and 3 months
description
Change in Quality of Life after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal
measure
Change in Quality of Life
time Frame
3 months

Full study description

brief Summary: 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.

Source references