Effects of Tamoxifen in Premenopausal Women With Benign Breast Disease Not at High-Risk of Developing Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00999921|
Recruitment Status : Completed
First Posted : October 22, 2009
Results First Posted : April 29, 2015
Last Update Posted : May 18, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Benign Breast Disease Fibrocystic Disease of Breast Fibroadenoma Mastalgia||Drug: Tamoxifen Drug: Evening Primrose Oil||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||256 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||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.|
|Study Start Date :||January 2008|
|Primary Completion Date :||August 2014|
|Study Completion Date :||January 2015|
U.S. FDA Resources
10 mg once daily from 5th day to 25th day of menstrual cycle for 3 months
Tamoxifen is given at 10 mg once daily between Day 5 and Day 25 of menstrual cycle for 3 cycles.
Experimental: Evening Primrose Oil
1000 mg daily for 3 months
Drug: Evening Primrose Oil
Evening Primrose Oil is given at 1000 mg two times daily for 3 months.
- Number of Participants Analysed for Reduction in Lump Size ( 60% Reduction in Lump Size Considered to be a Satisfactory Response) [ Time Frame: 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). [ Time Frame: 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
- Number of Participants Analysed for Response of Cyclical Mastalgia (Good Response Was Defined as Disappearance of Mastalgia) [ Time Frame: 3 months ]All patients who had an increase in breast pain in the "perimenstrual period" were designated as having cyclical mastalgia. Response was assessed following treatment in terms of either persistence of cyclical mastalgia after 3 months of treatment or disappearance of cyclical mastalgia
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00999921
|Department of Surgery, Medical College, Kolkata|
|Kolkata, West Bengal, India, 700073|
|Principal Investigator:||Md Tanveer Adil||Resident, Department of Surgery, Medical College and Hospital, Kolkata|
|Study Director:||Rumana Rahman||Resident, Department of Gynaecology and Obstetrics, Medical College and Hospital, Kolkata|
|Study Director:||Soumen Das||Resident, Department of Surgery, Medical College and Hospital, Kolkata|
|Study Director:||Sudip Sarkar||Resident, Department of Surgery, Medical College and Hospital, Kolkata|
|Study Director:||Rupesh Kumar||Resident, Department of Surgery, Medical College and Hospital, Kolkata|
|Study Chair:||Utpal De||Professor, Department of Surgery, Medical College and Hospital, Kolkata|