Back to resultsOmega-3 Fatty Acids Plus Vitamin E Cosupplementation Versus Vitamin E in Fibrocystic Breast Patient (FCC)
Primary Purpose
Mastalgia
Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Omega 3 fatty acid
VitaE
Sponsored by
About this trial
This is an interventional treatment trial for Mastalgia
Eligibility Criteria
Inclusion Criteria:
- all females with mastalgia aged 18 to 55
Exclusion Criteria:
Pregnant and lactating women, patient who had a recent breast abscess or breast drainage, patient used omega-3 and vitamin E supplementation before the trial and postmenopausal women.
-
Sites / Locations
- Rehab Sabry
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
No Intervention
Arm Label
group a
Group b
Group c
Arm Description
will receive omega 3 plus vitamin E
will receive vitamin E
no intervention just reassurance and analgesics on need
Outcomes
Primary Outcome Measures
improvement of pain severity
improvement of pain on visual analogue scale
Secondary Outcome Measures
improvement of radiological finding
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04694027
Brief Title
Omega-3 Fatty Acids Plus Vitamin E Cosupplementation Versus Vitamin E in Fibrocystic Breast Patient
Acronym
FCC
Official Title
Omega-3 Fatty Acids Plus Vitamin E Cosupplementation Versus Vitamin E in Fibrocystic Breast Patient
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2021 (Anticipated)
Primary Completion Date
March 2021 (Anticipated)
Study Completion Date
March 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
to identify the effect of omega-3 plus vitamin E cosupplementation on mastalgia in patients with FCC and to compare its effect with that of vitamin E only.
Detailed Description
120 patients will be enrolled in the study and divided into three groups each group consisted 40 patient then the severity of mastalgia in the three groups before, through and after intervention. Radiological assessment was done before and after the intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mastalgia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group a
Arm Type
Active Comparator
Arm Description
will receive omega 3 plus vitamin E
Arm Title
Group b
Arm Type
Active Comparator
Arm Description
will receive vitamin E
Arm Title
Group c
Arm Type
No Intervention
Arm Description
no intervention just reassurance and analgesics on need
Intervention Type
Drug
Intervention Name(s)
Omega 3 fatty acid
Intervention Description
omega 3 1000 mg
Intervention Type
Drug
Intervention Name(s)
VitaE
Intervention Description
vitamin e 400 mg
Primary Outcome Measure Information:
Title
improvement of pain severity
Description
improvement of pain on visual analogue scale
Time Frame
3 months
Secondary Outcome Measure Information:
Title
improvement of radiological finding
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
all females with mastalgia aged 18 to 55
Exclusion Criteria:
Pregnant and lactating women, patient who had a recent breast abscess or breast drainage, patient used omega-3 and vitamin E supplementation before the trial and postmenopausal women.
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rehab Sabry
Phone
0201063314476
Email
rehab.yassen@kasralainy.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Heba El nahas
Phone
020104810684
Email
hebagalal@kasralainy.edu.eg
Facility Information:
Facility Name
Rehab Sabry
City
Cairo
State/Province
Muslim
ZIP/Postal Code
11231
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rehab Sabry
Email
rehab.yassen@kasralainy.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Omega-3 Fatty Acids Plus Vitamin E Cosupplementation Versus Vitamin E in Fibrocystic Breast Patient
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