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

Primary Purpose

Benign Breast Disease, Fibrocystic Disease of Breast, Fibroadenoma

Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Tamoxifen
Evening Primrose Oil
Sponsored by
Medical College and Hospital Kolkata
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Breast Disease focused on measuring Fibrocystic Breast Disease, Fibroadenoma, Mastalgia

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Surgery, Medical College, Kolkata

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Tamoxifen

Evening Primrose Oil

Arm Description

10 mg once daily from 5th day to 25th day of menstrual cycle for 3 months

1000 mg daily for 3 months

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

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

Full Information

First Posted
October 21, 2009
Last Updated
April 28, 2015
Sponsor
Medical College and Hospital Kolkata
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1. Study Identification

Unique Protocol Identification Number
NCT00999921
Brief Title
Effects of Tamoxifen in Premenopausal Women With Benign Breast Disease Not at High-Risk of Developing Breast Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College and Hospital Kolkata

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Breast Disease, Fibrocystic Disease of Breast, Fibroadenoma, Mastalgia
Keywords
Fibrocystic Breast Disease, Fibroadenoma, Mastalgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
256 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tamoxifen
Arm Type
Experimental
Arm Description
10 mg once daily from 5th day to 25th day of menstrual cycle for 3 months
Arm Title
Evening Primrose Oil
Arm Type
Experimental
Arm Description
1000 mg daily for 3 months
Intervention Type
Drug
Intervention Name(s)
Tamoxifen
Intervention Description
Tamoxifen is given at 10 mg once daily between Day 5 and Day 25 of menstrual cycle for 3 cycles.
Intervention Type
Drug
Intervention Name(s)
Evening Primrose Oil
Intervention Description
Evening Primrose Oil is given at 1000 mg two times daily for 3 months.
Primary Outcome Measure Information:
Title
Number of Participants Analysed for Reduction in Lump Size ( 60% Reduction in Lump Size Considered to be a Satisfactory Response)
Description
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.
Time Frame
3 months
Title
Number of Participants Analysed for Reduction in Mastalgia (Cardiff Breast Pain Score).
Description
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
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Number of Participants Analysed for Response of Cyclical Mastalgia (Good Response Was Defined as Disappearance of Mastalgia)
Description
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
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Md Tanveer Adil
Organizational Affiliation
Resident, Department of Surgery, Medical College and Hospital, Kolkata
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rumana Rahman
Organizational Affiliation
Resident, Department of Gynaecology and Obstetrics, Medical College and Hospital, Kolkata
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Soumen Das
Organizational Affiliation
Resident, Department of Surgery, Medical College and Hospital, Kolkata
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sudip Sarkar
Organizational Affiliation
Resident, Department of Surgery, Medical College and Hospital, Kolkata
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rupesh Kumar
Organizational Affiliation
Resident, Department of Surgery, Medical College and Hospital, Kolkata
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Utpal De
Organizational Affiliation
Professor, Department of Surgery, Medical College and Hospital, Kolkata
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Surgery, Medical College, Kolkata
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700073
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
17509880
Citation
Srivastava A, Mansel RE, Arvind N, Prasad K, Dhar A, Chabra A. Evidence-based management of Mastalgia: a meta-analysis of randomised trials. Breast. 2007 Oct;16(5):503-12. doi: 10.1016/j.breast.2007.03.003. Epub 2007 May 16.
Results Reference
background
PubMed Identifier
455247
Citation
Allegra JC, Lippman ME, Green L, Barlock A, Simon R, Thompson EB, Huff KK, Griffin W. Estrogen receptor values in patients with benign breast disease. Cancer. 1979 Jul;44(1):228-31. doi: 10.1002/1097-0142(197907)44:13.0.co;2-0.
Results Reference
background
PubMed Identifier
9543585
Citation
Hurst JL, Mega JF, Hogg JP. Tamoxifen-induced regression of breast cysts. Clin Imaging. 1998 Mar-Apr;22(2):95-8. doi: 10.1016/s0899-7071(97)00076-4.
Results Reference
background
PubMed Identifier
12591986
Citation
Tan-Chiu E, Wang J, Costantino JP, Paik S, Butch C, Wickerham DL, Fisher B, Wolmark N. Effects of tamoxifen on benign breast disease in women at high risk for breast cancer. J Natl Cancer Inst. 2003 Feb 19;95(4):302-7. doi: 10.1093/jnci/95.4.302.
Results Reference
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Effects of Tamoxifen in Premenopausal Women With Benign Breast Disease Not at High-Risk of Developing Breast Cancer

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