Back to resultsOmega-3 Supplementation for Smell Dysfunction
Primary Purpose
Sellar/Parasellar Tumor, Smell Dysfunction
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Omega-3
Sponsored by
About this trial
This is an interventional treatment trial for Sellar/Parasellar Tumor focused on measuring Endoscopic Sellar/Parasellar Tumor Resection
Eligibility Criteria
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
Sites / Locations
- Stanford University
- Emory University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Omega-3 Supplementation Group
Control Group
Arm Description
Omega-3 supplementation
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02529332
First Posted
August 7, 2015
Last Updated
August 19, 2018
Sponsor
Stanford University
Collaborators
Emory University
1. Study Identification
Unique Protocol Identification Number
NCT02529332
Brief Title
Omega-3 Supplementation for Smell Dysfunction
Official Title
Effect of Omega-3 Supplementation in Patients With Smell Dysfunction Following Endoscopic Pituitary Tumor Resection
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
Emory University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sellar/Parasellar Tumor, Smell Dysfunction
Keywords
Endoscopic Sellar/Parasellar Tumor Resection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Omega-3 Supplementation Group
Arm Type
Experimental
Arm Description
Omega-3 supplementation
Arm Title
Control Group
Arm Type
No Intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3
Intervention Description
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.
Primary Outcome Measure Information:
Title
Difference in Olfactory Function at baseline, based upon tumor type (i.e. functional vs. non-functional tumor)
Description
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)
Title
Change in Olfactory Function over 6-month post-op period
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zara M Patel, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Omega-3 Supplementation for Smell Dysfunction
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