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

Cairo University (CU)

Status and phase: Unknown; Phase 4

Conditions: Mastalgia

Treatments: Drug: VitaE; Drug: Omega 3 fatty acid

Study type: Interventional

Funder types: Other

Identifiers

NCT04694027

Omega 3 & vit E for mastalgia

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 3 patient groups

group a

Active Comparator group

Description:

will receive omega 3 plus vitamin E

Treatment:

Drug: VitaE

Drug: Omega 3 fatty acid

Group b

Active Comparator group

Description:

will receive vitamin E

Treatment:

Drug: VitaE

Group c

No Intervention group

Description:

no intervention just reassurance and analgesics on need