Effects of Tamoxifen in Women With Benign Breast Disease Not Having Any Risks of Developing Breast Cancer
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.
Benign Breast Disease
Fibrocystic Disease of Breast
Drug: Evening Primrose Oil
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|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.|
- Reduction of Lump Size. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Reduction in Mastalgia (Cardiff Breast Pain Score). [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Response of Cyclical Mastalgia. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||January 2008|
|Study Completion Date:||October 2009|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
Tamoxifen is given at 10mg once daily between Day 5 and Day 25 of menstrual cycle for 3 cycles.
|Experimental: Evening Primrose Oil||
Drug: Evening Primrose Oil
Evening Primrose Oil is given at 1000 mg two times daily for 3 months.
Benign breast disease is frequently encountered in female patients, a significant proportion of who are premenopausal women. Established methods of treatment do not yield significant results. This is not only a social burden but also entails high economic cost. As such the quality of life of these patients is a matter of concern for both the patients and their families and to attending physicians. Reported effects of tamoxifen on benign breast disease in premenopausal non high risk patients are scarce. Moreover published data has not yet revealed association of estrogen receptors in different benign breast lesions.The variability of response and its relation with estrogen receptor status is still a field of active investigation.
|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 Chair:||Utpal De||Associate Professor, Department of Surgery, Medical College and Hospital, Kolkata|
|Study Director:||Rupesh Kumar||Resident, Department of Surgery, Medical College and Hospital, Kolkata|
|Study Director:||Pradipta Guha||Resident, Department of Medicine, 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|