FCC: Omega-3 Fatty Acids Plus Vitamin E Cosupplementation Versus Vitamin E in Fibrocystic Breast Patient

Sponsor

Cairo University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04694027

Collaborator

(none)

120

Enrollment

Location

Arms

1.9

Anticipated Duration (Months)

61.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Mastalgia	Drug: Omega 3 fatty acid Drug: VitaE	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Omega-3 Fatty Acids Plus Vitamin E Cosupplementation Versus Vitamin E in Fibrocystic Breast Patient

Anticipated Study Start Date :

Jan 1, 2021

Anticipated Primary Completion Date :

Mar 1, 2021

Anticipated Study Completion Date :

Mar 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: group a will receive omega 3 plus vitamin E	Drug: Omega 3 fatty acid omega 3 1000 mg Drug: VitaE vitamin e 400 mg
Active Comparator: Group b will receive vitamin E	Drug: VitaE vitamin e 400 mg
No Intervention: Group c no intervention just reassurance and analgesics on need

Arm

Intervention/Treatment

Active Comparator: group a

will receive omega 3 plus vitamin E

Drug: Omega 3 fatty acid

omega 3 1000 mg

Drug: VitaE

vitamin e 400 mg

Active Comparator: Group b

will receive vitamin E

Drug: VitaE

vitamin e 400 mg

No Intervention: Group c

no intervention just reassurance and analgesics on need

Outcome Measures

Primary Outcome Measures

improvement of pain severity [3 months]
improvement of pain on visual analogue scale

Secondary Outcome Measures

improvement of radiological finding [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rehab Sabry	Cairo	Muslim	Egypt	11231

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rehab Sabry, assistant lecturer, Cairo University

ClinicalTrials.gov Identifier:

NCT04694027

Other Study ID Numbers:

Omega 3 & vit E for mastalgia

First Posted:

Jan 5, 2021

Last Update Posted:

Jan 5, 2021

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Fibrocystic Breast Disease

Mastodynia

Study Results

No Results Posted as of Jan 5, 2021