Effects of Tamoxifen in Women With Benign Breast Disease Not Having Any Risks of Developing Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
Medical College and Hospital Kolkata
ClinicalTrials.gov Identifier:
NCT00999921
First received: October 21, 2009
Last updated: November 19, 2009
Last verified: November 2009

October 21, 2009
November 19, 2009
January 2008
August 2009   (final data collection date for primary outcome measure)
  • Reduction of Lump Size. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Reduction in Mastalgia (Cardiff Breast Pain Score). [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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
Response of Cyclical Mastalgia. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Effects of Tamoxifen in Women With Benign Breast Disease Not Having Any Risks 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 10mg once daily between Day 5 and Day 25 of menstrual cycle for 3 cycles.
  • Drug: Evening Primrose Oil
    Evening Primrose Oil is given at 1000 mg two times daily for 3 months.
  • Experimental: Tamoxifen
    Intervention: Drug: Tamoxifen
  • Experimental: Evening Primrose Oil
    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
October 2009
August 2009   (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
Not Provided
Md. Tanveer Adil, Resident, Department of Surgery, 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 Chair: Utpal De Associate Professor, Department of Surgery, Medical College and Hospital, Kolkata
Study Director: Rupesh Kumar Resident, Department of Surgery, Medical College and Hospital, Kolkata
Study Director: Pradipta Guha Resident, Department of Medicine, 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
Medical College and Hospital Kolkata
November 2009

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