Effects of Tamoxifen in Premenopausal Women With Benign Breast Disease Not at High-Risk of Developing Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Benign Breast Disease, Fibrocystic Disease of Breast, Fibroadenoma, Mastalgia

Intervention / Treatment
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* Drug: Tamoxifen
* Drug: Evening Primrose Oil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical, Radiographic and Histological diagnosis of Benign Breast Disease. Benign Breast disease amenable to hormonal therapy. Exclusion Criteria: Postmenopausal women. Premenopausal women with pregnancy or other contraindications to tamoxifen. Girls less than 16 years. Very large lesions which require surgery for cosmesis. High risk breast lesions like epitheliosis, atypia or atypical hyperplasia on histopathology or susceptible lesions prone to develop malignancy. Lesions like duct ectasia where hormone therapy is not likely to be of benefit. Inflammatory lesions which are amenable to antibiotic therapy or surgical drainage for treatment. Patients unwilling to undergo treatment.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tamoxifen<br>10 mg once daily from 5th day to 25th day of menstrual cycle for 3 months | Drug: Tamoxifen<br>* Tamoxifen is given at 10 mg once daily between Day 5 and Day 25 of menstrual cycle for 3 cycles.<br>|
| Experimental: Evening Primrose Oil<br>1000 mg daily for 3 months | Drug: Evening Primrose Oil<br>* Evening Primrose Oil is given at 1000 mg two times daily for 3 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Analysed for Reduction in Lump Size ( 60% Reduction in Lump Size Considered to be a Satisfactory Response) | 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. | 3 months | 
| Number of Participants Analysed for Reduction in Mastalgia (Cardiff Breast Pain Score). | 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 | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Analysed for Response of Cyclical Mastalgia (Good Response Was Defined as Disappearance of Mastalgia) | 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 | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibrocystic Breast Disease, Fibroadenoma, Mastalgia