NCT02529332 - Omega-3 Supplementation for Smell Dysfunction | Crick

Overview

Omega-3 supplementation has been shown to have neuroprotective and potentially anti-inflammatory properties in both central and peripheral nerve injuries. The investigators are studying to see if omega-3 supplementation will affect olfactory (smell) function in patients with olfactory dysfunction following endoscopic removal of pituitary tumors.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

110

Conditions

Sellar/Parasellar Tumor Smell Dysfunction

Interventions

Omega-3DIETARY_SUPPLEMENT

Nature Made Ultra Omega3 Fish Oil 1400mg softgels contains 1000mg of omega 3 per serving. Participants will be instructed to take twice daily for 6 months.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * sellar/parasellar tumor scheduled to undergo endoscopic transnasal transsphenoidal resection * 18 years of age or older * English speaking Exclusion Criteria: * Currently using blood thinning agents (aside from NSAIDs or cardioprotective ASA) * elevated AST, ALT, or alk phos \>10% outside of normal range, if randomized to omega-3 group * diabetes, if randomized to omega-3 group and not already on omega-3 prescribed by another provider * unable to provide informed consent due cognitive deficiencies

Locations (2)

Stanford University

Stanford, California, United States

Emory University Hospital

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

Difference in Olfactory Function at baseline, based upon tumor type (i.e. functional vs. non-functional tumor)

The University of Pennsylvania Smell Identification Test (UPSIT) will be used to determine baseline olfactory function prior to sellar/parasellar tumor resection for all subjects.The test consists of a total of 40 "scratch and sniff" strips which the individual must select the correct odor from four choices. The test is scored out of 40 items. The number of correct answers regarding the smells being experienced is the subject's score. The higher the score the better the sense of smell.

Time frame: Baseline (pre-tumor resection)

Change in Olfactory Function over 6-month post-op period

The University of Pennsylvania Smell Identification Test (UPSIT) will be used to determine baseline olfactory function prior to sellar/parasellar tumor resection for all subjects.The test consists of a total of 40 "scratch and sniff" strips which the individual must select the correct odor from four choices. The test is scored out of 40 items. The number of correct answers regarding the smells being experienced is the subject's score. The higher the score the better the sense of smell. A change in UPSIT scores of 10% or greater indicates a clinically significant improvement.

Time frame: Baseline (pre-tumor resection), at 6 months (post-tumor resection)