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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Md Tanveer Adil, Medical College and Hospital Kolkata
ClinicalTrials.gov Identifier:
NCT00999921
First received: October 21, 2009
Last updated: April 28, 2015
Last verified: April 2015

October 21, 2009
April 28, 2015
January 2008
August 2014   (final data collection date for primary outcome measure)
  • 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
Reduction of lump size, relief of mastalgia and response to cyclical mastalgia of benign breast disease. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00999921 on ClinicalTrials.gov Archive Site
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
Not Provided
Not Provided
Not Provided
 
Effects of Tamoxifen in Premenopausal Women With Benign Breast Disease Not at High-Risk of Developing Breast Cancer
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Benign Breast Disease
  • Fibrocystic Disease of Breast
  • Fibroadenoma
  • Mastalgia
  • Drug: Tamoxifen
    Tamoxifen is given at 10 mg once daily between Day 5 and Day 25 of menstrual cycle for 3 cycles.
    Other Name: Tamoxifen
  • Drug: Evening Primrose Oil
    Evening Primrose Oil is given at 1000 mg two times daily for 3 months.
    Other Name: Evening Primrose Oil
  • Experimental: Tamoxifen
    10 mg once daily from 5th day to 25th day of menstrual cycle for 3 months
    Intervention: Drug: Tamoxifen
  • Experimental: Evening Primrose Oil
    1000 mg daily for 3 months
    Intervention: Drug: Evening Primrose Oil

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
256
January 2015
August 2014   (final data collection date for primary outcome measure)

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.
Female
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00999921
MSVP-107/08
Yes
Md Tanveer Adil, Medical College and Hospital Kolkata
Medical College and Hospital Kolkata
Not Provided
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
Medical College and Hospital Kolkata
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP