A Single Blinded Randomized Controlled Trial of the Comparative Effects of Tamoxifen and Evening Primrose Oil in Premenopausal Non-high Risk Patients With Benign Breast Disease With Respect to the Estrogen Receptor Status.

NCT00999921 Phase 4 COMPLETED Results posted

The purpose of the study is to determine the efficacy and relapse rate of low dose, short duration treatment with tamoxifen in benign breast disease amenable to hormonal therapy with respect to etiology and estrogen receptor status and to realize its side-effects and cost of therapy. To do a comparative analysis of the results with evening primrose oil which is one of the first line management in benign breast disease.

Details

Lead sponsor	Medical College and Hospital Kolkata
Phase	Phase 4
Status	COMPLETED
Enrolment	256
Start date	2008-01
Completion	2015-01

Conditions

• Benign Breast Disease
• Fibrocystic Disease of Breast
• Fibroadenoma
• Mastalgia

Interventions

• Tamoxifen
• Evening Primrose Oil

Primary outcomes

• Number of Participants Analysed for Reduction in Lump Size ( 60% Reduction in Lump Size Considered to be a Satisfactory Response) — 3 months
  Ultrasonography of the breast was used to ascertain the lump size at the beginning of therapy and a repeat Ultrasonography of breast was done after 3 months at the end of the proposed therapy to record the posttreatment lump size by the same operator. The difference between the two findings were recorded and noted and a 60% or more reduction in the size of the lump was considered as a satisfactory response.
• Number of Participants Analysed for Reduction in Mastalgia (Cardiff Breast Pain Score). — 3 months
  All patients were categorized as Grade 0 for no pain, grade 1 for mild pain, grade 2 for moderate pain, Grade 3 for severe pain. Therapeutic response to mastalgia was expressed in terms of Cardiff Breast Pain Score (CBS) where CBS I = excellent response with no pain, CBS II = substantial response, CBS III = poor response and CBS IV = no response

Countries

India