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

April 28, 2015 updated by: Md Tanveer Adil, Medical College and Hospital Kolkata

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

256

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • West Bengal
      • Kolkata, West Bengal, India, 700073
        • Department of Surgery, Medical College, Kolkata

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tamoxifen
10 mg once daily from 5th day to 25th day of menstrual cycle for 3 months
Drug: Tamoxifen
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.

What is the study measuring?

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)
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.
3 months
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
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)
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical College and Hospital Kolkata

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

October 21, 2009

First Submitted That Met QC Criteria

October 21, 2009

First Posted (Estimate)

October 22, 2009

Study Record Updates

Last Update Posted (Estimate)

May 18, 2015

Last Update Submitted That Met QC Criteria

April 28, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSVP-107/08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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