Effects of Tamoxifen in Premenopausal Women With Benign Breast Disease Not at High-Risk 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.|
- Number of Participants Analysed for Reduction in Lump Size ( 60% Reduction in Lump Size Considered to be a Satisfactory Response) [ Time Frame: 3 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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
|Study Start Date:||January 2008|
|Study Completion Date:||January 2015|
|Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
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.
Other Name: Tamoxifen
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.
Other Name: Evening Primrose Oil
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|